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Clinical trials
catalyst calendar across sponsors →Studies where IART 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.
49 interventional · 32 observational · 41 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| AERA Pediatrics RegistryNCT07071298observationalFailure-free after ETBD with the AERA® device. | — | Recruiting | — | Dysfunction of Eustachian Tube | 300 | Oct 2030 | ≤ 1,534 d | 2026-07-07 |
| Post Market Clinical Follow-up of CODMAN CERTAS Programmable ValveNCT05397106observationalPrecise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment | — | Active, not recruiting | Device: CODMAN CERTAS Plus Programmable Valve | Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension, Brain Tumor, Post-Traumatic Hydrocephalus, Hemorrhagic Stroke | 160 | 2029-01-24 | in 889 d | 2026-02-27 |
| The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage EvacuationNCT04494295observationalRate of Surgical Success | — | Recruiting | Device: Aurora Surgiscope System | Supratentorial Hemorrhage | 500 | 2028-10-15 | in 788 d | 2026-02-06 |
| A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg UlcersNCT06453187Percentage of complete wound closure for target ulcerRandomized · Open-label · Treatment | Not applicable | Enrolling by invitation | Device: Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers, AmnioExcel Plus for Venous Leg Ulcers, AmnioExcel Plus for Diabetic Foot Ulcers · Procedure: Standard of Care | Diabetic Foot Ulcer, Venous Leg Ulcer | 350 | 2026-12-31 | in 134 d | 2026-07-27 |
| Bactiseal Catheter Safety Registry StudyNCT06276543observationalInfection outcome | — | Recruiting | Device: antibiotic-impregnated catheter | Hydrocephalus | 200 | 2026-07-31 | — | 2025-01-27 |
| Tissue Quality of Integra vs. BTM Treated BurnsNCT06760611observationalTime from Integra or BTM treated burns to autograft procedure | — | Withdrawnsponsor's stated reason: change in company prioritizations | — | Burn Injury, Burn Scar, Burn Wounds - Partial Thickness (2nd Degree), Skin Grafting | 0 | 2025-09-30actual | — | 2026-01-07 |
| MicroMatrix® Flex in Tunneling WoundsNCT06629506Relative rate of closure of a tunneling or undermining featureOpen-label · Treatment | Not applicable | Completed | Device: MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer | Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers, Draining Wound | 25 | 2025-08-31actual | — | 2026-03-05 |
| The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)NCT05113381Number of flushing interventions to address occlusionsOpen-label · Treatment | Not applicable | Completed | Device: CerebroFlo™ EVD Catheter | Intraventricular Hemorrhage, Subarachnoid Hemorrhage | 105 | 2025-07-31actual | — | 2025-08-15 |
| The SurgiMend PRS Retrospective StudyNCT05182177observationalPerformance of SurgiMend | — | Completed | Device: SurgiMend PRS | Reconstructive Surgical Procedures | 84 | 2024-12-31actual | — | 2025-02-14 |
| External Ventricular Drainage Post-Market Clinical Follow-up RegistryNCT05652296results2026-01-28observationalAnticipated Drainage of Cerebrospinal Fluid (CSF)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: External Ventricular Drainage (EVD) | Cerebrospinal; Disorder | 120 | 2024-12-16actual | — | 2026-01-28 |
| The CUSA Clarity Bone Tip StudyNCT04300075observationalEffectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale | — | Withdrawnsponsor's stated reason: Business Decision | Device: CUSABT | Cranial Skull Base Bone Removal | 0 | Aug 2024 | — | 2023-08-07 |
| Suturable DuraGen™ PMCF StudyNCT04923867observationalPatient Outcome | — | Completed | Device: Suturable DuraGen™ | Cerebrospinal Fluid Leak | 106 | 2024-07-31actual | — | 2025-04-06 |
| Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health StudyNCT06297187observationalProportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata | — | Completed | Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator) | Vulvar Intraepithelial Neoplasia, Condylomata Acuminata | 56 | 2024-07-31actual | — | 2024-09-19 |
| REINVENT Registry (Registry of the Nerve Gap Repair From Integra)NCT05339594observationalThe primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD). | — | Terminatedsponsor's stated reason: Slow Enrollment, Sponsor Decision | Device: NeuraGen, NeuraGen 3D | Peripheral Nerve Injuries | 17 | 2024-06-03actual | — | 2024-07-11 |
| AmnioExcel® Plus vs SOC in the Management of Diabetic Foot UlcersNCT05024656Incidence of complete wound closureRandomized · Open-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: Sponsor decision | Other: AmnioExcel Plus Amniotic Membrane, Standard of Care | Diabetic Foot Ulcer | 0 | Feb 2024 | — | 2021-11-02 |
| T-GENVIH-003 LTFU (Long Term Follow Up) StudyNCT06034652results2025-05-20observationalNumber of Participants With Clinically Confirmed RecurrenceStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Integra® Gentrix® Surgical Matrix | Hernia, Hernia, Ventral, Pathological Conditions, Anatomical, Hernia, Abdominal | 8 | 2024-01-19actual | — | 2025-05-20 |
| NeuraGen 3D Pilot StudyNCT05343143The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Slow Enrollment, Sponsor Decision | Device: NeuraGen 3D Nerve Guide Matrix | Digital Nerve Injury | 1 | 2023-07-11actual | — | 2024-05-16 |
| Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia RepairNCT05610267results2024-06-18observationalIncidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index ProcedureStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Retrospective chart review | Ventral Hernia | 28 | 2022-12-28actual | — | 2024-06-18 |
| The CUSA Clarity Soft Tissue Removal StudyNCT04298268observationalEffectiveness of soft tissue removal per surgeon assessment. | — | Completed | Device: CUSA Clarity Ultrasonic Surgical Aspirator System use | Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal | 100 | 2021-11-24actual | — | 2022-02-08 |
| CERTAS Programmable Valve RegistryNCT04207229observationalPerformance Endpoints | — | Completed | Device: CODMAN CERTAS Programmable Valves | Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension | 35 | 2021-11-18actual | — | 2022-01-26 |
| ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative StudyNCT02021279The safety and effectiveness of surgical success/failure.Non-randomized · Open-label · Treatment | Not applicable | Completed | Device: MatriStem Pelvic Floor Matrix · Procedure: native tissue repair | Pelvic Organ Prolapse | 161 | 2021-04-28actual | — | 2022-02-08 |
| Bactiseal Catheter Safety Registry in ChinaNCT04496414results2021-12-21observational50 Participants With Non-infection Within One YearStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Bactiseal Catheter | Hydrocephalus | 50 | 2020-11-30actual | — | 2023-03-28 |
| PriMatrix for the Management of Diabetic Foot UlcersNCT03010319results2022-03-15Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment PhaseRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device | Diabetic Foot Ulcer | 226 | Aug 2020actual | — | 2022-04-29 |
| A Study on the Safety of Hakim Programmable Shunt SystemNCT04285489results2021-09-21observationalNumber of Participants With Non-infection Within One YearStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Hakim Shunt Programmable System | Hydrocephalus | 130 | 2020-07-28actual | — | 2021-11-05 |
| A Study to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the HandNCT03598023Time to Complete Wound HealingRandomized · Open-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: Sponsor discretion | Device: Cytal® Burn Matrix, EZ-Derm® Porcine Xenograft | Partial Thickness Burn of Hand | 0 | 2020-07-01 | — | 2021-04-01 |
| Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of CareNCT03626623results2021-02-15Number of Wounds With Wound ClosureRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Sponsor Discretion | Device: Cytal Wound Matrix 1-Layer · Other: Standard of Care (SOC) | Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 | 15 | 2020-02-18actual | — | 2021-08-25 |
| Cytal® Wound Matrix and MicroMatrix® Wound StudyNCT03632954results2021-05-11observationalNumber of Participants With Completely Healed WoundsStudy Protocol and Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: Sponsor Decision | Device: ACell Arm | Wounds | 37 | 2020-01-27actual | — | 2021-05-11 |
| Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure InjuriesNCT03283787results2020-11-16Incidence of Complete EpithelializationRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy | Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer | 60 | 2019-09-25actual | — | 2021-04-20 |
| The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case SeriesNCT04041037results2020-07-15observationalRate of Wound ClosureStudy Protocol and Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: Sponsor Decision | Device: Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix | Pilonidal Disease | 2 | 2019-08-30actual | — | 2021-04-20 |
| Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)NCT03816202results2022-01-14observationalEvidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and RemovalStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Sundt carotid shunt | Carotid Artery Stenosis | 100 | 2019-08-27actual | — | 2022-01-14 |
| AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot UlcersNCT03547635results2020-07-20The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Other: AMNIOEXCEL Plus Amniotic Membrane, Standard of Care · Device: A Marketed Comparator | Diabetic Foot Ulcer | 116 | 2019-02-26actual | — | 2020-07-20 |
| A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot UlcersNCT01270633Percent of study ulcers healedRandomized · Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Business Decision | Device: PriMatrix · Other: Standard of Care | Foot Ulcer, Diabetic | 30 | Sep 2017actual | — | 2017-12-02 |
| MEDIHONEY® Gel Versus Collagenase for Wound DebridementNCT02482948Necrotic tissue reductionRandomized · Single-masked · Treatment | Not applicable | Terminatedsponsor's stated reason: Poor enrollment. | Device: Active Leptospermum Honey (Medihoney) · Drug: Collagenase | Ulcer, Wounds | 10 | Mar 2017actual | — | 2017-12-02 |
| A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg UlcersNCT01612806Percent of VLUs healed by week 12 post-randomizationRandomized · Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Site selection | Device: PriMatrix, PriMatrix Ag · Procedure: moist wound therapy | Venous Stasis Ulcer | 31 | Feb 2017actual | — | 2024-04-01 |
| SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy RadiotherapyNCT01959867Capsular Contracture RateNon-randomized · Open-label · Treatment | Not applicable | Withdrawn | Device: SurgiMend® PRS · Other: No Intervention | Breast Cancer | 0 | Jan 2017actual | — | 2017-01-10 |
| Study of Safety and Efficacy for the Eustachian Tube Balloon CatheterNCT02087150results2019-01-08Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 WeeksRandomized · Open-label · Treatment | Not applicable | Completed | Device: Acclarent Eustachian Tube Balloon Catheter (ETBC) | Eustachian Tube Dysfunction | 323 | 2016-12-01actual | — | 2024-07-12 |
| Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrixNCT01729286Complete wound closureRandomized · Single-masked · Treatment | Not applicable | Terminated | Device: PriMatrix Moist Wound Therapy · Other: Standard of Care Moist Wound Therapy | Foot Ulcer, Diabetic | 92 | Sep 2016actual | — | 2016-10-18 |
| DuraSeal Exact Spine Sealant System Post-Approval StudyNCT01410864observationalPost-operative CSF leaks | — | Completed | Device: DuraSeal Exact Spine Sealant System · Other: Control | Dural Sealing | 924 | Jul 2016actual | — | 2017-03-01 |
| Duragen® Secure Post Marketing Clinical Follow-up (PMCF)NCT02225080results2018-08-16observationalPatient's Outcome | — | Completed | — | Dura Mater Nick Cut or Tear, Surgery | 100 | Jun 2016actual | — | 2018-10-09 |
| Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone ImplantNCT01824706observationalExplantation rate after 2 years of follow-up | — | Completed | Procedure: craniectomy | Surgery | 110 | 2016-05-01actual | — | 2018-07-02 |
| Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot UlcersNCT01830348The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later).Randomized · Quadruple-masked · Treatment | Phase 3 | Terminated | Drug: DSC127, placebo vehicle gel | Diabetic Foot Ulcers | 266 | Dec 2015actual | — | 2017-12-12 |
| Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic UseNCT01840085The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatmentOpen-label · Treatment | Phase 3 | Terminated | Drug: 0.03% DSC127 topical gel | Diabetic Foot Ulcer | 261 | Dec 2015actual | — | 2017-12-12 |
| Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot UlcersNCT01849965The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed 2 weeks later) after initiation of treatment.Randomized · Quadruple-masked · Treatment | Phase 3 | Terminated | Drug: DSC127, placebo vehicle gel, Standard of Care gel, Aquasite | Diabetic Foot Ulcers | 396 | Dec 2015actual | — | 2017-12-12 |
| A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot UlcersNCT01858545results2018-03-29Number of Participants With Complete Wound ClosureRandomized · Single-masked · Treatment | Not applicable | Terminated | Device: MatriStem, Cellular Dermal Replacement Tissue | Foot Ulcer, Diabetic | 56 | Dec 2015actual | — | 2021-04-15 |
| Global Sinus Surgery RegistryNCT02347943results2019-02-27observationalNumber of Participants Completing Follow-Up Visits | — | Terminated | — | Chronic Rhinosinusitis, Recurrent Acute Rhinosinusitis | 252 | 2015-11-01actual | — | 2024-07-12 |
| Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)NCT01714687results2019-03-11CSS Total Score Change From Baseline to 24 Week VisitRandomized · Single-masked · Treatment | Not applicable | Completed | Device: balloon sinus dilation · Other: medical therapy | Recurrent Acute Rhinosinusitis | 59 | 2015-10-01actual | — | 2024-07-12 |
| Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot UlcersNCT02209051Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatmentRandomized · Open-label · Treatment | Not applicable | Completed | Other: AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers | Diabetic Foot Ulcers | 29 | Aug 2015actual | — | 2017-12-02 |
| Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic RhinosinusitisNCT01685229results2019-05-13observationalComparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline | — | Completed | Device: Balloon sinus dilation · Drug: Medical Management | Sinusitis | 198 | 2015-04-01actual | — | 2024-07-12 |
| Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex WoundsNCT01947387observationalWound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy. | — | Completed | — | Complex Lower Extremity Soft Tissue Reconstruction | 320 | Sep 2014actual | — | 2016-12-02 |
| Large Abdominal Hernia Repair With SurgiMend 3.0NCT00892333observationalHernia recurrence | — | Completed | — | Hernia | 122 | Jul 2014actual | — | 2016-05-17 |
| Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up StudyNCT02369497observationalAmerican Shoulder and Elbow Surgeons (ASES) Score | — | Terminatedsponsor's stated reason: PI left institution and site did not have resources to continue study | Device: HRA | Arthritis | 59 | Jul 2014actual | — | 2015-02-24 |
| A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot UlcersNCT01060670results2016-09-22Incidence of Complete Wound ClosureRandomized · Open-label · Treatment | Not applicable | Completed | Device: Integra® Dermal Regeneration Template · Other: Conventional Wound Therapy | Neuropathic Diabetic Ulcer - Foot | 545 | Jun 2014actual | — | 2016-09-22 |
| The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded TrialNCT01228500Time to healingDouble-masked · Treatment | Not applicable | Withdrawn | Device: PriMatrix | Foot Ulcer, Diabetic | 0 | Jan 2013actual | — | 2016-05-17 |
| Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic RhinosinusitisNCT01455948The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.Randomized · Single-masked · Health services research | Not applicable | Terminated | Device: Relieva Balloon Sinuplasty™ System · Procedure: Functional Endoscopic Sinus Surgery | Chronic Rhinosinusitis | 25 | Nov 2012actual | — | 2024-07-11 |
| A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot UlcersNCT01228526observationalPercent of study ulcers healed | — | Completed | Device: PriMatrix | Foot Ulcers, Diabetic | 22 | Sep 2012actual | — | 2016-08-26 |
| Earset Healthy Volunteer StudyNCT01611246observationalNumber of subjects anesthetized as assessed by Wong-Baker scale | — | Completed | Device: Iontophoresis System With Earset | Otitis Media | 22 | 2012-08-01actual | — | 2024-07-11 |
| inVENT-In-Office StudyNCT01324271results2014-11-25Percentage of Subjects With In-office Tube Placement Procedure SuccessOpen-label · Treatment | Not applicable | Completed | Device: Acclarent Tympanostomy Tube Delivery system (TTDS) | Otitis Media | 85 | May 2012actual | — | 2024-08-06 |
| inVENT-visIOn StudyNCT01444391results2014-09-19Number of Subjects With Procedural, Serious and Device-related Adverse Events.Open-label · Treatment | Not applicable | Completed | Device: Tympanostomy tube placement (Acclarent iontophoresis device) | Otitis Media | 42 | May 2012actual | — | 2024-07-12 |
| Tympanostomy Tube Placement in Children in the Office (Inova Study)NCT01496287results2014-07-24Number of Participants With Procedural, Serious, and Device-Related Adverse EventsOpen-label · Treatment | Not applicable | Completed | Device: Tube Delivery System (TDS) | Otitis Media | 70 | Apr 2012actual | — | 2024-08-06 |
| Healthy Volunteer StudyNCT01346332observationalPain scores on visual analog scale | — | Completed | Device: Iontophoresis System with Headset | Anesthesia of Tympanic Membrane | 106 | 2012-02-01actual | — | 2024-07-11 |
| Optimization and Refinement of Technique in In-Office Sinus Dilation 2NCT01107379results2014-09-18observationalMean Intra-patient Change in SNOT-20 Score | — | Completed | Device: Relieva Balloon Sinuplasty System | Sinusitis | 203 | Jan 2012actual | — | 2024-08-06 |
| Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone AcetonideNCT00791934results2014-07-14Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.Open-label · Treatment | Not applicable | Completed | Device: Stratus Microflow Ethmoid Spacer | Sinusitis | 63 | Nov 2011actual | — | 2024-08-06 |
| Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory ApparatusNCT00941993results2014-08-04Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator AssessmentOpen-label · Other | Not applicable | Completed | Device: Iontophoresis System (Acclarent) | Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media | 109 | Jan 2011actual | — | 2024-07-12 |
| DuraGen Plus® Adhesion Barrier for Use in Spinal SurgeryNCT00387829results2013-11-20Radiological, Pain, and Functional Outcome AssessmentsRandomized · Double-masked · Treatment | Not applicable | Terminatedsponsor's stated reason: Sponsor voluntarily terminated study | Device: DuraGen Plus Adhesion Barrier Matrix | Spinal Injuries, Adhesions | 347 | Dec 2010actual | — | 2017-09-07 |
| Evaluation of the Tympanostomy Tube Delivery SystemNCT01202578results2014-07-11Safety of Tympanostomy Tube (TT) Delivery SystemOpen-label · Treatment | Phase 2/3 | Completed | Device: tympanostomy tube | Otitis Media With Effusion, Acute Otitis Media | 53 | Nov 2010actual | — | 2024-08-06 |
| An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal SurgeryNCT01002287results2014-01-29The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.Randomized · Single-masked · Prevention | Not applicable | Terminatedsponsor's stated reason: Study was terminated for business purposes, not for safety or efficacy reasons. | Device: SprayShield Adhesion Barrier System · Procedure: Good Surgical Technique Alone | Ulcerative Colitis, Familial Polyposis | 11 | Oct 2010actual | — | 2014-11-20 |
| Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube InsertionNCT02150044results2014-09-25Ear Outcome SuccessOpen-label · Treatment | Not applicable | Completed | Device: Acclarent Tympanostomy Tube Delivery System (TTDS). | Otitis Media | 29 | Oct 2010actual | — | 2024-07-12 |
| PleuraSeal Pivotal Study (US)NCT00748124Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Interim analysis results were not supportive of primary endpoint | Device: PleuraSeal Sealant System · Procedure: Standard Tissue Closure Techniques | Open Thoracotomy | 230 | Sep 2010actual | — | 2014-09-11 |
| Singapore Tympanostomy Tube Delivery System StudyNCT01046877results2014-11-18Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.Open-label · Treatment | Not applicable | Completed | Device: Tympanostomy Tube Delivery System | Otitis Media | 25 | Aug 2010actual | — | 2024-08-06 |
| Anesthetizing the Tympanic Membrane in Healthy VolunteersNCT01047904Procedural SuccessOpen-label · Treatment | Not applicable | Completed | Device: Acclarent Iontophoresis System | Evaluate Performance and Reliability of Iontophoresis System | 21 | Nov 2009actual | — | 2024-07-11 |
| Study to Evaluate Safety & Effectiveness of Spinal SealantNCT00444067results2012-08-21Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)Randomized · Single-masked · Treatment | Not applicable | Completed | Device: Spinal Sealant · Other: Standard of Care | Cerebrospinal Fluid Leakage, Subdural | 98 | Aug 2009actual | — | 2017-09-07 |
| Safety and Efficacy of Balloon Sinuplasty in Pediatric SinusitisNCT00939471results2012-08-17Safety: Device-related Adverse Events During Balloon Dilation Through 12 MonthsOpen-label · Treatment | Not applicable | Completed | Device: Relieva™ Balloon Sinuplasty™ System | Chronic Sinusitis | 44 | 2009-07-01actual | — | 2024-07-12 |
| Clinical Study of the Tympanostomy Tube Delivery SystemNCT00939796results2014-06-09Device SuccessOpen-label · Treatment | Not applicable | Completed | Device: Acclarent Tympanostomy Tube Delivery System | Otitis Media With Effusion | 16 | Jun 2009actual | — | 2024-08-06 |
| Balloon Sinus Dilation In Office or ORNCT00939393results2014-10-03Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to BaselineNon-randomized · Open-label · Health services research | Not applicable | Completed | Device: FESS instruments with or without balloon treatment, Balloon Sinuplasty | Chronic Sinusitis | 72 | 2009-06-01actual | — | 2024-07-12 |
| DuraSeal Sealant Post Market StudyNCT00704340results2010-07-28Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.Randomized · Single-masked · Treatment | Not applicable | Completed | Device: DuraSeal Dural Sealant System · Other: Standard of Care | Elective Cranial Procedures With Dural Incision | 237 | May 2009actual | — | 2017-09-07 |
| Post Market Study for an Adhesion Barrier Following Laparoscopic MyomectomyNCT00891657results2010-08-31Number of Sites Adherent to the UterusRandomized · Single-masked · Prevention | Not applicable | Completed | Device: SprayShield™ | Fibroid, Myoma, Leiomyoma | 15 | May 2009actual | — | 2017-09-07 |
| PleuraSeal Post Market Study (Europe)NCT00704171results2010-03-15Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.Randomized · Single-masked · Treatment | Phase 4 | Completed | Procedure: Standard Tissue Closure Techniques · Device: PleuraSeal Lung Sealant System | Lung Disease, Pulmonary Lobectomy | 121 | Dec 2008actual | — | 2016-10-27 |
| Study to Evaluate Safety & Effectiveness of Vascular Sealant SystemNCT00439309results2014-04-01Sealing SuccessRandomized · Single-masked · Treatment | Not applicable | Terminatedsponsor's stated reason: Business Decision | Device: Gelfoam/Thrombin, VascuSeal | Peripheral Vascular Disease | 69 | May 2008actual | — | 2017-09-07 |
| Study to Evaluate Safety and Effectiveness of Spinal SealantNCT00594035results2009-12-03Watertight Dural ClosureRandomized · Single-masked · Treatment | Not applicable | Completed | Device: Spinal Sealant System, Standard of care | Spinal Procedure Requiring Dura Incision | 158 | Feb 2008actual | — | 2017-09-07 |
| Clinical Evaluation of the Ethmoid Sinus SpacerNCT01054703results2010-02-24Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implantOpen-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study. | Device: Ethmoid Sinus Spacer | Sinusitis, Chronic Rhinosinusitis | 14 | 2007-11-01actual | — | 2024-08-06 |
| Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)NCT00231062results2011-07-08Number of Sinuses With Patency of Sinus Ostium After SinuplastyNon-randomized · Open-label · Treatment | Phase 3 | Completed | Device: Sinuplasty | Chronic Sinusitis | 115 | Jun 2006actual | — | 2024-08-06 |
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