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Clinical trials
catalyst calendar across sponsors →Studies where COLO-B.CO is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
132 interventional · 18 observational · 87 with posted results
Held by 0 tracked-famous managers · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| CP382 - Intermittent Catheter (IC) PRO Panel PlanNCT07475468observationalNumber of IC products used by subjects. | — | Not yet recruiting | Other: No Intervention: Observational Cohort | Intermittent Catheterization | 1,000 | 2032-09-30 | in 2,233 d | 2026-05-13 |
| CP384 - Ostomy Care (OC) PRO Panel PlanNCT07589907observationalNumber of OC products used by subjects. | — | Not yet recruiting | — | Ostomy, Ileostomy - Stoma, Urostomy | 1,000 | 2032-09-30 | in 2,233 d | 2026-05-15 |
| Urine Research BiobankNCT07769606observationalTotal bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline | — | Recruiting | Other: urinesample collection | UTI | 50 | 2027-12-31 | in 498 d | 2026-08-18 |
| Peristeen Light Explorative Clinical InvestigationNCT07126327Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).Open-label · Treatment | Not applicable | Recruiting | Device: Peristeen Light - trans anal irrigation system | Faecal Incontinence, Constipation - Functional | 60 | 2026-08-01 | — | 2026-04-14 |
| Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI ScannerNCT07384559Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).Open-label · Basic science | Not applicable | Not yet recruiting | Other: MRI scan | Retention, Urinary | 20 | 2026-07-31 | — | 2026-02-03 |
| Prospective Longitudinal Study of Heylo™ for People Living With a StomaNCT06554015observationalPrimary endpoint | — | Recruiting | — | Stoma Ileostomy | 100 | 2026-07-01 | — | 2025-09-04 |
| Feasibility of a Newly Developed Ostomy PrototypeNCT07146035To test the system performance of the prototype.Open-label · Device feasibility | Not applicable | Not yet recruiting | Device: CP369 Feasibility of a newly developed ostomy prototype (only one intervention) | Stoma - Ileostomy | 10 | 2025-09-30 | — | 2025-08-28 |
| INTIBIA Pivotal StudyNCT05250908Response RateRandomized · Quadruple-masked · Treatment | Not applicable | Active, not recruiting | Device: INTIBIA Therapeutic, INTIBIA Non-Therapeutic | Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations | 208 | 2025-05-12actual | — | 2026-03-02 |
| A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary IncontinenceNCT04098822observationalPatient Global Impression of Improvement (PGI-I) | — | Recruiting | Device: Virtue male sling | Urinary Incontinence, Stress | 130 | Dec 2024 | — | 2023-02-21 |
| Clinical Investigation Exploring a Newly Developed Ostomy BaseplateNCT07376421Maximum itching scale 0-10)Randomized · Open-label · Treatment | Not applicable | Completed | Device: Incestigational device, Comparator | Stoma Ileostomy | 20 | 2026-04-09actual | — | 2026-05-01 |
| Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.NCT07316530Maximum itchingRandomized · Open-label · Treatment | Not applicable | Completed | Device: CP381 | Stoma Ileostomy | 13 | 2026-01-09actual | — | 2026-01-23 |
| New Coating for Urinary Intermittent CathetersNCT06985888Overall discomfort of the catheterisationRandomized · Double-masked · Treatment | Not applicable | Completed | Device: SpeediCath® Standard male new coating, SpeediCath® Standard male | Retention, Urinary | 32 | 2025-06-30actual | — | 2025-08-14 |
| CP376 OCT Exploratory Skin StudyNCT06965140Thickness of the epidermal layer (assessed by OCT)Open-label · Other | Not applicable | Completed | Device: flat 1-piece open ostomy device | Stoma Ileostomy | 12 | 2025-05-02actual | — | 2025-05-18 |
| A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg UlcersNCT05923749Wound healingRandomized · Open-label · Treatment | Not applicable | Completed | Device: Biatain Ag, Cutimed Siltec Sorbact | Wound Heal | 180 | 2025-01-29actual | — | 2025-05-22 |
| TFL Driven Urinary System Treatment StudyNCT06257368observationalTime in Laser ON | — | Unknown status | Device: Coloplast TFL Drive | Urologic Diseases | 373 | Dec 2024 | — | 2024-02-15 |
| Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse RepairNCT06296316observationalThe incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up | — | Terminatedsponsor's stated reason: From June 08, 2024, the study device was no longer marketed in France. Therefore, the sponsor decided to terminate the study prematurely. | Device: Restorelle Polypropylene Mesh | Genital Prolapse | 39 | 2024-11-06actual | — | 2026-01-28 |
| Investigation of a New Rectal Catheter for Users of Transanal IrrigationNCT06389396results2025-06-12Was it Possible to Perform Transanal Irrigation?Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: CP362 Test Catheter | Bowel Management | 20 | 2024-07-30actual | — | 2025-06-12 |
| A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal SkinNCT05641168Adherent areaRandomized · Open-label · Screening | Not applicable | Completed | Other: Adhesive material, Standard adhesive material | Skin Abnormalities | 114 | 2024-05-30actual | — | 2025-09-04 |
| Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg UlcersNCT05873257results2025-06-03Mean Relative Wound Area Reduction as Indication of Total Wound HealingOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Biatain Fiber Ag applied to participants | Venous Leg Ulcer | 50 | 2024-05-17actual | — | 2025-06-03 |
| Investigation of the Clinical Performance of Biatain Fiber Ag on BurnsNCT05824026results2025-09-11Percentage of Wounds Healed Within 14 DaysOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Gelling fiber wound dressing with silver | Partial-thickness Burn | 52 | 2024-04-26actual | — | 2025-09-11 |
| Clinical Investigation Exploring Two Ostomy Product PrototypesNCT06237686results2025-06-26Primary ObjectiveOpen-label · OtherStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: CP363 | Stoma Ileostomy | 11 | 2024-02-02actual | — | 2025-06-26 |
| A Clinical Investigation Evaluating Peristeen® PerformanceNCT05381610The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen.Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Lack of enrollment - Sponsor decision | Device: Peristeen | Neurogenic Bowel | 6 | 2024-01-01actual | — | 2024-02-15 |
| Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of CareNCT05786612results2025-03-05Percentage Wound Area Reduction (WAR) During Four WeeksRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber | Venous Leg Ulcer, Diabetic Foot Ulcer | 102 | 2023-12-27actual | — | 2025-03-05 |
| Clinical Trial of New Intermittent Single-use CatheterNCT05814211results2025-02-20Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)Randomized · Single-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve, Comparator device #2 - SpeediCath Compact Plus Female | Urinary Incontinence | 82 | 2023-11-29actual | — | 2025-02-20 |
| Clinical Trial of New Single-use Compact Intermittent CatheterNCT05841004results2025-01-23Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Investigational device, Comparator device | Urinary Incontinence | 73 | 2023-09-14actual | — | 2025-01-23 |
| Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a StomaNCT05652010results2024-11-26Leakage Through Coupling Registered at Each Bag Change (Yes/no)Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: New 2-piece Coupling, SenSura Mio Click | Surgical Stomas | 51 | 2023-07-15actual | — | 2025-02-19 |
| An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent CatheterizationNCT05626686results2024-04-15Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.Open-label · OtherStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: CLINY catheter | Urinary Incontinence | 40 | 2023-03-30actual | — | 2024-04-15 |
| A Confirmatory Study Confirming Performance of a New Intermittent CatheterNCT05485935results2025-03-18Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation ProfileRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Investigational device - intermittent catheter with micro-hole zone, Comparator - standard intermittent catheter | Urinary Retention | 73 | 2023-01-03actual | — | 2025-03-18 |
| Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at RiskNCT05619003results2025-09-10Number of Adverse EventsOpen-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Biatain Silicone Sacral dressing | Pressure Injury Prevention | 67 | 2022-12-08actual | — | 2026-05-29 |
| Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy ProductNCT05200416results2025-01-23Emotional Impact Score (Scale From 0-100)Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Heylo, Standard of Care | Ileostomy - Stoma, Colostomy Stoma | 144 | 2022-11-04actual | — | 2025-01-23 |
| Performance of a Single-use Intermittent Micro-hole Zone CatheterNCT05485922results2025-03-05Number of Flow-stop EpisodesRandomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Investigational device - intermittent catheter with a micro-hole zone, Comparator device -VaPro intermittent catheter | Urinary Incontinence, Retention, Urinary | 42 | 2022-11-04actual | — | 2025-03-05 |
| Investigate Bladder and Prostate During Emptying With Intermittent CatheterNCT05560594Bladder morphologyOpen-label · Other | Not applicable | Completed | Device: Coloplast SpeediCath CH12 standard male intermittent catheter | Urinary Function | 12 | 2022-08-25actual | — | 2022-10-18 |
| Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma FormationNCT05135754results2024-08-21Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 WeeksOpen-label · Supportive careStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Heylo | Stoma Ileostomy, Stoma Colostomy | 100 | 2022-08-22actual | — | 2024-08-21 |
| The Nordic Consensus StudyNCT04763863results2024-09-05observationalEvaluate Body Assessment Tool Based on the Nurse Evaluation FormStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Other: Body Assessment Tool, Clinical usability evaluation of the Body Assessment Tool | Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy, Colostomy Stoma | 121 | 2022-07-28actual | — | 2024-09-05 |
| Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone CatheterNCT05224544results2025-01-13Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Investigational prototype device, Comparator device | Urinary Incontinence | 43 | 2022-03-31actual | — | 2025-12-12 |
| A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection TechnologyNCT04868617results2025-04-30The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)Randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: ATTRACT-I | Peristomal Skin Complication | 89 | 2022-02-13actual | — | 2025-04-30 |
| Randomized Clinical Trial on Transanal IrrigationNCT04586634results2024-07-22LARS ScoreRandomized · Open-label · Supportive careStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Peristeen cone catheter | Low Anterior Resection Syndrome | 32 | 2021-12-10actual | — | 2024-07-22 |
| Altis® 522 Trial - Treatment of Female Stress Urinary IncontinenceNCT02348112results2023-11-21observationalPrimary Effectiveness EndpointStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Altis Single Incision Sling, Transobturator or Retropubic Sling | Stress Urinary Incontinence | 416 | Sep 2021actual | — | 2023-12-04 |
| A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary IncontinenceNCT04115605results2026-05-26observationalTreatment SuccessStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: The minimum of enrolled subject defined in the protocol was 180 patients and it was greatly exceeded. Therefore the study was terminated by the sponsor to perform the study analysis. | Device: Altis Single Incision Sling | Urinary Incontinence, Stress | 598 | 2021-09-22actual | — | 2026-05-26 |
| Investigation of a Supporting Ostomy Product Intended for Leakage DetectionNCT04894084results2023-08-01System Performance Accuracy of PicturesOpen-label · Supportive careStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: CP321 | Stoma Ileostomy | 25 | 2021-07-14actual | — | 2023-09-22 |
| Investigation of Non-CE Marked Intermittent Catheters for FemalesNCT04557787results2023-09-21Residual Urine at 1st Flow-stop During Nurse CatheterizationRandomized · Single-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females | Retention, Urinary | 15 | 2021-05-31actual | — | 2023-09-21 |
| Investigation of Non-CE Marked Intermittent Catheters.NCT04543136results2023-07-13Residual Urine at 1st Flow-stop During Nurse CatheterizationRandomized · Single-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males | Retention, Urinary | 16 | 2021-01-31actual | — | 2023-07-13 |
| Evaluation of a New Supporting Ostomy ProductNCT04374890Wear timeOpen-label · Other | Not applicable | Unknown status | Device: CP308 | Stoma Ileostomy | 30 | Dec 2020 | — | 2020-05-05 |
| Exploratory Study of a New Urine Collection Device for MenNCT04672993results2024-02-08Percentage of Participants That Found the Product to be Comfortable to WearOpen-label · OtherStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Urine collection device for men | Urinary Incontinence | 20 | 2020-12-01actual | — | 2024-02-08 |
| Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids DeviceNCT03784989observationalMedian wear time | — | Withdrawnsponsor's stated reason: Lack of recruitment | — | Stoma Ileostomy | 0 | 2020-09-08actual | — | 2022-11-17 |
| Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a StomaNCT03929978observationalMedian wear time | — | Withdrawnsponsor's stated reason: lack of recruitment | — | Stoma Ileostomy | 0 | 2020-09-08actual | — | 2025-03-11 |
| Investigation of New Intermittent Catheters in Healthy VolunteersNCT04445051results2023-07-03Residual Urine at 1st Flow-stopRandomized · Single-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female | Retention, Urinary | 30 | 2020-09-01actual | — | 2023-07-03 |
| A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the SkinNCT04544566results2021-05-06Mean Adherent Area Measured by Photo of Used TapeRandomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Test product A, Test product B, Comparator | Stoma Site Leakage | 12 | 2020-08-21actual | — | 2021-05-06 |
| Investigation of a New Stoma Product for People With a StomaNCT04101318results2023-09-21Max Itching Within a Week at Steady StateRandomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Non-Conformité Européene marked product, Conformité Européene marked competitor products | Peristomal Skin Complication | 79 | 2020-07-17actual | — | 2023-09-21 |
| Evaluation of the Peel Force of New Adhesives From the SkinNCT03200444results2025-04-25Peel ForceOpen-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Other: Standard adhesive 1, Standard adhesive 2, Standard adhesive 3, P-4, P-15, P-16 | Stoma Ileostomy | 6 | 2020-06-30actual | — | 2025-04-25 |
| Restorelle® Mesh Versus Native Tissue Repair for ProlapseNCT02162615observationalRecurrence of Prolapse | — | Completed | Device: Restorelle Direct Fix A, Restorelle Direct Fix P · Procedure: Native Tissue Repair Anterior, Native Tissue Repair Posterior | Pelvic Organ Prolapse | 810 | 2020-01-15actual | — | 2022-01-27 |
| Investigation of New Intermittent Catheter Swelling Media in Healthy VolunteersNCT04633291results2023-07-17Overall Discomfort During Nurse CatheterizationRandomized · Single-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Novel swelling media, Comparator swelling media | Catheter Site Pain, Catheter Site Discomfort | 22 | 2019-11-28actual | — | 2023-07-17 |
| The European Study of Altis Single Incision Sling System for Female Stress Urinary IncontinenceNCT02049840Proportion of subjects who meet the criteria of cure at 12 monthsOpen-label · Treatment | Not applicable | Completed | Device: Altis Single Incision Sling System | Stress Urinary Incontinence | 153 | 2019-11-04actual | — | 2021-09-28 |
| Evaluation of Urine Samples and Their Relation to Urinary Tract InfectionNCT03522766observationalType of bacteria present in the urine | — | Completed | Other: urine sample | Urinary Tract Infections | 30 | 2019-09-23actual | — | 2020-02-05 |
| Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent CatheterNCT04250987results2020-09-21Number of Participants With Readability of Pressure Sensor MeasurementsOpen-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SpeediCath(R) | Compliance, Patient | 12 | 2019-04-04actual | — | 2020-09-21 |
| Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a StomaNCT03770078results2025-04-01Trans Epidermal Water LossOpen-label · Supportive careStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Test Product A | Ileostomy - Stoma, Colostomy Stoma | 23 | 2019-03-06actual | — | 2025-04-01 |
| Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy VolunteersNCT04231149results2025-03-24Urine Flow RateRandomized · Single-masked · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Test product 2, Test product 3, Comparator | Compliance, Patient | 9 | 2018-12-20actual | — | 2025-03-24 |
| Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market StudyNCT01541748results2020-06-18observationalPercentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.Study Protocol and Statistical Analysis Plan ↗ | — | Completed | Other: Axis | Pelvic Organ Prolapse | 74 | 2018-11-11actual | — | 2020-06-30 |
| An Investigation Exploring Adhesive Materials and Their Ability to Handle MoistureNCT02818257Peel force used to removed adhesiveRandomized · Open-label · Basic science | Not applicable | Completed | Other: Strip A, Strip B, Strip C | Healthy Volunteers | 27 | 2018-10-13actual | — | 2019-02-01 |
| Evaluation of the Ability of Newly Developed Adhesives to Absorb MoistureNCT03619226results2025-07-11Resistance (Moisture in the Adhesive)Open-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Other: test patch | Stoma Ileostomy | 6 | 2018-07-04actual | — | 2025-07-11 |
| Exploratory Study Investigating Urodynamic Parameters During CatheterisationNCT03337048results2024-08-12Discomfort During Catheter Insertion on a Visual Analogue ScaleOpen-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SpeediCath | Spinal Cord Injuries, Enlarged Prostate With Lower Urinary Tract Symptoms | 30 | 2018-05-29actual | — | 2024-08-12 |
| Assessment of the Performance of a New Ostomy Device in Subjects Having an IleostomyNCT03439241wear time (hours)Randomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast ostomy device | Ileostomy - Stoma | 20 | 2018-04-16actual | — | 2018-06-06 |
| Assessment of New Ostomy Devices in Subjects Having an IleostomyNCT03427203Trans epidermal water lossRandomized · Open-label · Supportive care | Not applicable | Completed | Device: SenSura Mio, Coloplast Ostomy device 1, Coloplast Ostomy device, Coloplast Ostomy device 3 | Ileostomy - Stoma | 35 | 2018-04-06actual | — | 2018-06-06 |
| Investigating the Performance of a New Adhesive StripNCT03423134trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: New adhesive strip | Ileostomy - Stoma | 6 | 2018-02-20actual | — | 2019-02-01 |
| Investigating the Adhesion of New Adhesive to the SkinNCT03439176Swelling of the adhesiveOpen-label · Basic science | Not applicable | Unknown status | Other: Standard adhesive 1, Standard adhesive 2, PL4, PL16-L | Ileostomy - Stoma | 6 | 2018-02-15actual | — | 2020-01-27 |
| A Clinical Investigation Evaluating Three New 1-piece Ostomy ProductsNCT03154944results2025-03-28Trans Epidermal Water LossRandomized · Open-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Ostomy device 1, Ostomy device 2, Ostomy device 3 | Ileostomy - Stoma | 38 | 2018-02-02actual | — | 2025-03-28 |
| Evaluation of the Performance of an Adhesive StripNCT03419013Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: New adhesive strip | Ileostomy - Stoma | 7 | 2018-01-22actual | — | 2018-02-01 |
| Assessement of the Peal Force Needed to Peel New Adhesives From the SkinNCT03289013Swelling of the adhesiveOpen-label · Other | Not applicable | Completed | Other: Standard adhesive 1, Standard adhesive 2, LT-2, LT-21, LT-25, 33-20 | Ileostomy - Stoma | 5 | 2017-12-21actual | — | 2018-02-01 |
| Evaluation of the Influence of Output on Skin Wearing a New AdhesiveNCT03200431Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: New adhesive strip | Ileostomy - Stoma | 6 | 2017-12-11actual | — | 2018-02-01 |
| Assessment of the Effect of Output on New AdhesivesNCT03331783Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Standard hydrocolloid adhesive patch, LT-2, LT-21, 33-20 | Ileostomy - Stoma | 5 | 2017-10-17actual | — | 2018-02-01 |
| Evaluation of the Effect of Output on New AdhesivesNCT03257774Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Adhesive strip A, Adhesive strip B, Adhesive strip C | Ileostomy - Stoma | 6 | 2017-09-13actual | — | 2017-11-08 |
| Evaluation of the Effect of Output on Newly Developed AdhesivesNCT03200418Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Standard hydrocolloid adhesive, P-4, P-15, P-16 | Ileostomy - Stoma | 6 | 2017-09-04actual | — | 2017-11-08 |
| Evaluation of the Performance of a New Adhesive StripNCT03257787Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: new adhesive strip | Ileostomy - Stoma | 6 | 2017-08-23actual | — | 2017-11-08 |
| The Influence of Output on Skin Covered by Adhesive With TopfilmNCT03044275Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: New adhesive strip, Standard adhesive strip | Ileostomy - Stoma | 15 | 2017-05-10actual | — | 2017-05-31 |
| Evaluation of the Influence of New Adhesives of Output on SkinNCT03044262Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Standard adhesive strip, New adhesive strip | Stoma Ileostomy | 15 | 2017-04-25actual | — | 2017-05-31 |
| Evaluation of the Influence of Output on Skin Covered by AdhesivesNCT03000881Trans Epidermal Water LossOpen-label · Basic science | Not applicable | Completed | Other: standard adhesive, New adhesive strip | Ileostomy - Stoma | 15 | 2017-04-04actual | — | 2017-05-31 |
| Evaluation of the Effect of Output on Skin Covered by a New AdhesiveNCT03044288Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: New adhesive strip, Standard adhesive strip | Ileostomy - Stoma | 6 | 2017-02-09actual | — | 2017-05-31 |
| Quality of Life in Patients With Double Loop Ureteral Stent (JJ Silicone Hydrogel Study)NCT02489656USSQ scale (Ureteral Stent Symptoms Questionnaire)Randomized · Single-masked · Treatment | Phase 4 | Unknown status | Device: Double Loop Ureteral stent endoscopic placement. | Kidney Calculi | 140 | Dec 2016 | — | 2015-07-03 |
| Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy VolunteersNCT02965105PainRandomized · Single-masked · Basic science | Not applicable | Completed | Device: Coloplast Test Catheter, Speedicath | Incontinence, Urinary | 28 | Dec 2016actual | — | 2017-03-01 |
| Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)NCT02992444Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Standard adhesive strip, Experimental adhesive strip | Ileostomy - Stoma | 5 | Dec 2016actual | — | 2025-08-28 |
| Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy VolunteersNCT02965066PainRandomized · Single-masked · Basic science | Not applicable | Completed | Device: Coloplast Test Catheter, Coloplast Speedicath | Incontinence, Urinary | 28 | Nov 2016actual | — | 2016-11-16 |
| A Pilot Evaluation of Adhesives and How They Are Impacted by OutputNCT02886442Peel forceOpen-label · Basic science | Not applicable | Completed | Other: Standard adhesive strip, New adhesive strip | Ileostomy-stoma | 4 | Sep 2016actual | — | 2016-10-13 |
| Evaluation of the Influence of Output on Skin Covered by Newly Developed AdhesivesNCT02886455Trans epidermal water lossOpen-label · Basic science | Not applicable | Completed | Other: Standard adhesive strip, New adhesive strip | Ileostomy - Stoma | 4 | Sep 2016actual | — | 2016-10-13 |
| Investigating the Safety and Performance of SenSura Test Product in Subjects With IleostomyNCT02887144Degree of leakageRandomized · Double-masked · Supportive care | Not applicable | Completed | Device: SenSura, SenSura test product | Stoma Ileostomy | 72 | Aug 2016actual | — | 2016-09-02 |
| Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or ColostomyNCT02675634results2017-09-05Fit to BodyRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test A, Coloplast Test B, Subjects own product | Ileostomy, Colostomy | 55 | Jun 2016actual | — | 2017-10-16 |
| Virtue® European StudyNCT01608789Improvement of urinary incontinence based on 24-hour pad testOpen-label · Treatment | Not applicable | Completed | Device: Virtue® Male Sling | Stress Urinary Incontinence | 123 | 2016-06-28actual | — | 2020-06-11 |
| Product Evaluation of a Newly Developed Intermittent Catheter.NCT02966015results2017-12-08Number of Participants Successfully Able to Insert CatheterOpen-label · Supportive care | Not applicable | Completed | Device: Coloplast test catheter | Incontinence, Urinary | 153 | May 2016actual | — | 2018-02-28 |
| A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy ProductsNCT02517541results2018-09-06Leakage Under the Baseplate (cm^2)Open-label · Basic science | Not applicable | Completed | Device: SenSura Mio Convex Soft | Ileostomy - Stoma, Colostomy | 74 | Mar 2016actual | — | 2022-11-16 |
| A Pilot Evaluation of Adhesives and How They Are Impacted by Output (Round 1b)NCT02626260Remaining adhesive area of adhesiveOpen-label · Basic science | Not applicable | Completed | Other: adhesive strip | Ileostomy | 4 | Mar 2016actual | — | 2025-08-27 |
| An Exploratory Study Investigating Adhesive Reaction to OutputNCT02594085Remaining adherent area of the adhesiveRandomized · Open-label · Basic science | Not applicable | Completed | Other: Patch 1, Patch 2, Patch 3, Patch 4, patch 5, Patch 6 | Ileostomy | 15 | Jan 2016actual | — | 2016-01-20 |
| A Pilot Evaluation of Adhesives and How They Are Impacted by Out-putNCT02610907Remaining adhesive area of adhesiveOpen-label · Basic science | Not applicable | Completed | Other: Buffer, Own output, simulated output | Ileostomy | 4 | Jan 2016actual | — | 2016-01-20 |
| Exair® Versus Native Tissue Repair for ProlapseNCT02162628observationalRecurrence of Prolapse | — | Terminatedsponsor's stated reason: Device voluntarily withdrawn from commercial use by manufacturer | Device: Exair Prolapse Repair System · Procedure: Total Native Tissue Repair | Pelvic Organ Prolapse | 79 | Dec 2015actual | — | 2015-12-14 |
| Evaluation of the Influence of Output on a Newly Develop AdhesiveNCT02886403Peel force used to removed the adhesive from the skinOpen-label · Basic science | Not applicable | Completed | Other: Standard adhesive strip, New adhesive strip | Ileostomy - Stoma | 5 | Nov 2015actual | — | 2016-09-01 |
| Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or ColostomyNCT02362360results2016-10-11Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".Randomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test Product, Comparator (Hollister) | Ileostomy, Colostomy | 52 | May 2015actual | — | 2016-10-11 |
| An Exploratory Study Investigating Human Skin Reaction to OutputNCT02351791results2023-10-02Trans Epidermal Water Loss After Test of Patches.Randomized · Open-label · Basic science | Not applicable | Completed | Other: Patch 1, Patch 2, Patch 3, Patch 4, Patch 5, Patch 6 | Ileostomy | 22 | Mar 2015actual | — | 2023-10-02 |
| An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy ProductsNCT02351817results2015-11-30Product AcceptanceRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Test A, Test B, Baseline | Ileostomy | 10 | Mar 2015actual | — | 2016-01-06 |
| The Influence of Adhesive Wafer Design on Fit to the BodyNCT02176954Fit to bodyRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Test A, Test B, Comparator | Ostomy - Ileostomy or Colostomy | 40 | Feb 2015actual | — | 2015-03-23 |
| Intermittent Catheterization in Spinal Cord Injured MenNCT02230540results2016-02-15Residual Volume Less Than 100mlNon-randomized · Open-label · Basic science | Not applicable | Terminated | Device: SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+, Product B SelfCath and urine bag, Conveen Contour | Spinal Cord Injuries | 8 | Sep 2014actual | — | 2016-03-15 |
| Virtue® Male Sling Fixation StudyNCT01170728observationalImprovement of incontinence | — | Terminatedsponsor's stated reason: The study has been terminated due to lack of subject enrollment. | Device: Coloplast Virtue® Male Sling | Stress Urinary Incontinence | 44 | Jun 2014actual | — | 2015-08-24 |
| Investigation of Newly Developed Ostomy Products in Subjects With IleostomyNCT01994902results2016-01-12Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast test product, SenSura Convex Light | Stoma Ileostomy | 129 | Jun 2014actual | — | 2016-01-12 |
| Investigation of a New 1-piece Convex Ostomy ProductNCT02043782results2015-12-08Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test, Own product, Competitor soft convex | Stoma Ileostomy, Stoma Colostomy | 38 | Apr 2014actual | — | 2016-05-04 |
| Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-pieceNCT01957553results2014-09-08PreferenceRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast test product, SenSura | Ileostomy - Stoma | 130 | Dec 2013actual | — | 2014-09-08 |
| The Influence of Baseplate Adhesive on the Degree of LeakageNCT01995357results2015-02-03Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test A, Coloplast Test B, Standard product | Colostomy Stoma, Ileostomy Stoma | 22 | Dec 2013actual | — | 2015-02-03 |
| Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market StudyNCT01378065results2015-10-28observationalPalpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | — | Completed | Device: Restorelle Direct Fix A&P | Pelvic Organ Prolapse (POP) | 31 | Sep 2013actual | — | 2020-05-12 |
| Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-pieceNCT01957488results2014-09-17LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura | Ileostomy - Stoma | 183 | Sep 2013actual | — | 2020-09-10 |
| Safety and Performance of New 1-piece Ostomy ProductNCT01800916results2014-05-30Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C, SenSura 1-Piece | Stoma Ileostomy | 65 | May 2013actual | — | 2017-04-14 |
| Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and ColostomyNCT01957462results2014-08-11Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test V, Coloplast Test X | Ileostomy - Stoma, Colostomy - Stoma | 31 | May 2013actual | — | 2016-09-26 |
| Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With IleostomyNCT01957475results2014-08-11Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test product Y, Coloplast Test product Z | Stoma - Ileostomy | 20 | May 2013actual | — | 2016-09-20 |
| Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With IleostomyNCT01800890results2014-08-06Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast A, Coloplast B, Coloplast C, SenSura Click | Subjects With an Ileostomy | 31 | Apr 2013actual | — | 2014-08-06 |
| Safety and Performance of a New Coating for Urinary Intermittent CathetersNCT01800903results2014-03-14Overall Discomfort During CatheterizationRandomized · Single-masked · Treatment | Not applicable | Completed | Device: ZN-D catheter, ZN-C catheter, SpeediCath catheter | Intermittent Urethral Catheterization | 40 | Apr 2013actual | — | 2020-09-10 |
| Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSuraNCT01799239results2013-12-05Leakage (Percentage of All Baseplates With Leakage)Randomized · Open-label · Supportive care | Not applicable | Completed | Device: Test product, SenSura | Ileostomy - Stoma | 32 | Mar 2013actual | — | 2016-09-30 |
| Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With IleostomyNCT01957397results2014-04-07Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test 1, Coloplast Test 2, Coloplast Test 3 | Ileostomy - Stoma | 26 | Nov 2012actual | — | 2016-09-30 |
| Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With IleostomyNCT01994863results2015-03-11LeakageRandomized · Open-label · Prevention | Phase 2 | Terminatedsponsor's stated reason: Problems with product performance | Device: Coloplast Test product, Standard Care | Ileostomy - Stoma | 23 | Nov 2012actual | — | 2015-03-11 |
| Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With IleostomyNCT01994876results2014-04-07Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test 1, Coloplast Test 2 | Ileostomy - Stoma | 18 | Nov 2012actual | — | 2014-04-07 |
| A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.NCT02064231results2014-04-04Degree of LeakageRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Coloplast Test A, Coloplast Test B, Own product, Coloplast Test C, Coloplast Test D | Ileostomy - Stoma | 28 | Aug 2012actual | — | 2020-09-10 |
| The Altis® Single Incision Sling System for Female Stress Urinary Incontinence StudyNCT01272284results2013-11-28Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 MonthsOpen-label · Treatment | Not applicable | Completed | Device: Altis® Single Incision Sling System (SIS) | Stress Urinary Incontinence | 113 | Jul 2012actual | — | 2021-02-11 |
| Performance Study of Newly Developed Ostomy ProductsNCT01513330results2014-01-09Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)Randomized · Open-label · Prevention | Phase 4 | Completed | Device: SenSura Mio, Standard Care | Stoma Colostomy | 122 | Jun 2012actual | — | 2014-01-09 |
| Human Skin Test Model in ColostomistsNCT01918085results2014-03-12Peel ForceRandomized · Open-label | Not applicable | Completed | Other: Hydrocolloid strip, Strata strip | Colostomy Stoma | 22 | May 2012actual | — | 2014-03-12 |
| Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard CareNCT01957384results2014-02-14Degree of LeakageRandomized · Open-label | Not applicable | Completed | Device: Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) | Ileostomy - Stoma | 25 | May 2012actual | — | 2014-03-27 |
| Quality of Life Intermittent Catheter StudyNCT01523743results2014-05-22Quality of Life (0-100 Point)Randomized · Open-label · Supportive care | Phase 4 | Completed | Device: SpeediCath Compact, Standard care | Neurogenic Bladder Dysfunction Nos | 125 | Apr 2012actual | — | 2016-09-30 |
| A Clinical Investigation of New Ostomy AppliancesNCT01523756results2014-03-10Leakage Under the Base Plate Using a 24-point ScaleRandomized · Open-label | Not applicable | Completed | Device: test product 1: new ostomy base plate with Coloplast as manufacturer, test product 2: new ostomy base plate with Coloplast as manufacturer | Leakage | 20 | Apr 2012actual | — | 2014-03-10 |
| An Investigation of Ostomy DevicesNCT01514136results2015-01-29Degree of LeakageOpen-label | Not applicable | Completed | Device: Ostomy appliance: convex 1-piece drainable | Ileostomy | 32 | Dec 2011actual | — | 2015-03-11 |
| Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects IleostomyNCT01448629Leakage underneath the baseplateRandomized · Open-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: The study was withdrawn because of problems found with the baseplate | Device: Standard Care, River | Leakage, Skin Condition | 0 | Jul 2011actual | — | 2012-02-07 |
| Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy VolunteersNCT01292941Discomfort during catheterisation measured by VAS-scale (0-10)Randomized · Single-masked · Supportive care | Phase 1 | Withdrawnsponsor's stated reason: Product development project closed prematurely | Device: Intermittent catheterisation, NonCE marked intermittent catheter/red, NonCE marked intermittent catheter/green, NonCE marked intermittent catheter/blue | Spinal Cord Injury | 0 | Jun 2011 | — | 2015-08-07 |
| Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard CareNCT01517178results2015-03-13Degree of Output Under the Base Plate (Leakage).Randomized · Open-label · Treatment | Phase 3 | Terminated | Device: New ostomy base plate (SS), Standard Care base plate | Leakage, Skin Condition | 33 | Jun 2011actual | — | 2015-03-13 |
| Physiotulle vs Urgotul in the Treatment of Leg UlcerNCT01238419pain at dressing removalRandomized · Open-label · Treatment | Phase 4 | Completed | Device: Physiotulle, URGOTUL | Leg Ulcers | 188 | May 2011actual | — | 2011-09-05 |
| Clinical Investigation of Filter Improvement for New Filter to Ostomy BagsNCT01272869results2012-12-31Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.Randomized · Open-label · Supportive care | Not applicable | Completed | Device: SenSura, Morfeus | Ileostomy - Stoma | 20 | Mar 2011actual | — | 2012-12-31 |
| Clinical Investigation for New Filter to Ostomy BagsNCT01273038results2013-04-01Frequency of Ballooning in the Morfeus and SenSura Test Period.Randomized · Open-label · Supportive care | Not applicable | Completed | Device: Morfeus, SenSura | Colostomy | 20 | Mar 2011actual | — | 2013-04-01 |
| Virtue® Male Incontinence Sling StudyNCT00856778results2014-04-14Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)Open-label · Treatment | Not applicable | Completed | Device: Virtue® Male Incontinence Sling | Stress Urinary Incontinence | 98 | Jan 2011actual | — | 2014-04-29 |
| Investigation of the Performance of Ostomy Base PlateNCT01103466results2013-04-04Leakage Under the Base PlateRandomized · Open-label · Treatment | Not applicable | Completed | Device: Atlas, SenSura, Conform 2 | Ileostomy - Stoma | 41 | Dec 2010actual | — | 2013-04-04 |
| Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and ComfortNCT01243294results2011-06-22Leakage (Percent of All Base Plates With Leakage)Randomized · Open-label | Phase 2/3 | Completed | Device: SS, SenSura | Colostomy | 56 | Nov 2010actual | — | 2011-10-07 |
| Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring SkinNCT01245413results2013-01-01Visual Inspection of Baseplate LooseningRandomized · Open-label · Basic science | Not applicable | Completed | Device: SenSura, Athena | Healthy | 32 | Nov 2010actual | — | 2013-01-01 |
| Bladder Scan of Residual Urine With New CatheterNCT01048541results2012-09-03Mean Residual Urine VolumeRandomized · Triple-masked · Treatment | Phase 2/3 | Completed | Device: Test Catheter - SpeediCath Compact Male, SpeediCath | Urinary Incontinence | 37 | Jun 2010actual | — | 2012-09-03 |
| Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)NCT00731666results2013-11-28The Study's Primary Objective Will Assess the Change in Penile Length.Open-label · Treatment | Not applicable | Completed | Device: Inflatable Penile Prosthesis | Erectile Dysfunction | 40 | May 2010actual | — | 2013-11-28 |
| Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy VolunteersNCT01142115results2011-08-09Discomfort Measured on the Visual Analog Scale (VAS)Randomized · Single-masked · Treatment | Not applicable | Completed | Device: Intermittent catheter CP063CC, SpeediCath | Spinal Cord Injury | 41 | May 2010actual | — | 2011-10-07 |
| Coloplast DialogueStudyNCT00626821results2012-03-12Quality of Life (Scale 0(Worst)-100(Best))Non-randomized · Open-label · Treatment | Phase 4 | Completed | Device: SenSura | Stoma | 3,017 | Apr 2010actual | — | 2012-03-12 |
| Biatain Ag vs Biatain in the Treament of Leg UlcersNCT00807664results2017-12-11Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at BaselineRandomized · Single-masked · Treatment | Not applicable | Completed | Device: Biatain Ag, Biatain | Leg Ulcers | 182 | Apr 2010actual | — | 2018-01-16 |
| A Randomised, Cross-over, Open-labelled Test Catheter Acceptance StudyNCT00990093results2012-09-05Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.Randomized · Open-label · Treatment | Not applicable | Completed | Device: test intermittent catheter, Intermittent catheterization | Spinal Cord Injuries | 36 | Mar 2010actual | — | 2012-09-05 |
| Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract InfectionsNCT00318591results2011-05-25Occurrence of Symptomatic Urinary Tract Infections (UTIs)Randomized · Open-label · Prevention | Not applicable | Completed | Device: SpeediCath, Conveen Uncoated | Urinary Tract Infections | 219 | Oct 2009actual | — | 2021-02-10 |
| Titan® One Touch Release Inflatable Penile ProsthesisNCT00731939results2014-04-14Assess the Ease of Deflation of the Titan® OTR PumpOpen-label · Treatment | Not applicable | Completed | Device: Inflatable Penile Prosthesis | Erectile Dysfunction | 124 | Oct 2009actual | — | 2014-04-14 |
| Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg UlcersNCT00628004Adverse eventsNon-randomized · Open-label · Treatment | Not applicable | Completed | Device: Biatain Ibu, Local best practice | Leg Ulcers | 93 | Jul 2009actual | — | 2017-04-26 |
| A Randomised Cross-over Study With Two 1-piece Urostomy Bags.NCT00765388results2014-03-11Preference of Sensura vs ModermaRandomized · Open-label | Phase 4 | Completed | Device: SenSura Uro, Hollister | Urostomy | 27 | May 2009actual | — | 2014-03-11 |
| Biatain Ibu vs. Biatain in Painful Chronic Venous Leg UlcersNCT00627094results2017-02-07Pain ReliefRandomized · Triple-masked · Treatment | Not applicable | Completed | Device: Biatain, Biatain Ibu | Leg Ulcers | 120 | Apr 2009actual | — | 2017-09-15 |
| Test Catheter Pilot Study in Healthy VolunteersNCT00832078results2012-09-05DiscomfortRandomized · Single-masked · Treatment | Not applicable | Completed | Device: SpeediCath Compact Male, Speedicath | Healthy | 28 | Apr 2009actual | — | 2012-09-05 |
| Conveen Optima Urisheaths With Collecting Bags Versus AbsorbentsNCT01056666Impact on quality of lifeRandomized · Open-label · Treatment | Phase 4 | Completed | Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine, absorbent protection | Urinary Incontinence | 61 | Feb 2009actual | — | 2011-09-19 |
| Comparison of Two Urostomy Bags (2-piece).NCT00761748results2013-01-01Preference of the Two Urostomy ProductsRandomized · Open-label | Phase 3 | Completed | Device: Convatec Uro 2-piece, SenSura Uro 2-piece | Urostomy Patent | 30 | Jan 2009actual | — | 2013-01-01 |
| A Feasibility Study of a Fecal Incontinence Management System for Medical UseNCT00556972results2013-01-01The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)Open-label · Supportive care | Not applicable | Terminatedsponsor's stated reason: Due to numerous delays in study start-up process... | Device: Fecal Incontinence Management System | Fecal Incontinence | 4 | Apr 2008actual | — | 2022-12-06 |
| Feasibility Study of a New Fistula Pouching SystemNCT00294450Nurse's preference to use the test product in the futureOpen-label · Treatment | Phase 2/3 | Completed | Device: Fistula Pouching System | Cutaneous Fistula | 22 | Mar 2007actual | — | 2012-02-01 |
| Evaluation of Residual Urine After Intermittent CatheterisationNCT00324233results2013-01-01Residual Urine Measured by Ultra SoundRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Intermittent catheter, Compact intermittent catheter | Healthy | 36 | Jun 2006actual | — | 2013-01-01 |
| Safety Study of Textile Binder for Abdominal CompressionNCT00385892Intra Abdominal Pressure (IAP)Non-randomized · Open-label · Treatment | Not applicable | Terminated | Device: Abdominal binder | Healthy | 11 | — | — | 2006-10-11 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19