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Clinical trials
catalyst calendar across sponsors →Studies where ISRG 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.
25 interventional · 36 observational · 3 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| European Real-World Registry for Use of the Ion Endoluminal SystemNCT06923774observationalDiagnostic Yield | — | Recruiting | Device: Ion endoluminal system | Pulmonary Nodule, Lung Cancer | 1,200 | Oct 2029 | ≤ 1,169 d | 2026-08-04 |
| A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted BronchoscopyNCT07761351Diagnostic Efficacy of the Assigned Biopsy ProcedureRandomized · Open-label · Diagnostic | Phase 4 | Not yet recruiting | Procedure: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT), CT-guided percutaneous lung nodule biopsy | Lung Cancer (Diagnosis), Lung Nodule | 550 | 2028-04-30 | in 620 d | 2026-08-12 |
| GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsNCT05867927observationalNumber of complications related to the surgery up to 30 days | — | Recruiting | Device: Robotic-assisted surgery (da Vinci), Non-da Vinci Surgery | GYN Disorders | 1,250 | Dec 2027 | ≤ 499 d | 2026-07-15 |
| Lung cAncer Robotic Comparative StudyNCT06038227observationalPatient reported Quality of Life 1 | — | Recruiting | Procedure: Robotic Assisted Thoracic Surgery, Video Assisted Thoracic Surgery | Lung Cancer | 512 | 2027-12-30 | in 498 d | 2026-04-06 |
| Real World Registry for Use of the Ion Endoluminal SystemNCT06004440observationalPrimary Endpoint to Assess Diagnostic Yield | — | Active, not recruiting | Device: Ion Endoluminal System | Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases | 1,301 | Aug 2027 | ≤ 377 d | 2026-04-24 |
| Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing MastectomyNCT03892980Primary Effectiveness: No conversions to open NSMOpen-label · Prevention | Not applicable | Active, not recruiting | Device: Nipple-Sparing Mastectomy | Nipple Sparing Mastectomy | 145 | 2027-04-30 | in 254 d | 2025-12-18 |
| IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal SurgeryNCT07346066Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.Open-label · Prevention | Phase 3 | Recruiting | Drug: filricianine | Ureter Injury | 146 | 2027-04-30 | in 254 d | 2026-08-05 |
| Open Nipple Sparing Mastectomy (NSM)NCT04447339observationalSafety Endpoint: complication rate | — | Active, not recruiting | Procedure: Nipple Sparing Mastectomy | Nipple Sparing Mastectomy | 75 | 2026-12-31 | in 134 d | 2026-03-24 |
| Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairNCT07655505Incidence of major adverse eventsOpen-label · Treatment | Not applicable | Enrolling by invitation | Device: Mitral Valve Repair including the use of Force Feedback instruments | Mitral Regurgitation (MR) | 30 | 2026-12-31 | in 134 d | 2026-08-17 |
| CoSMAP Trial: SP-EA vs MP-TA Robot-Assisted Radical ProstatectomyNCT07666217observationalIncidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications | — | Active, not recruiting | — | Prostate Cancer | 625 | 2026-09-30 | in 42 d | 2026-06-24 |
| A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 RobotNCT06879912observationalTo assess the force imparted on the tissue by force feedback instruments. | — | Recruiting | — | Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic, Gynecologic, Partial Nephrectomy | 200 | Aug 2026 | ≤ 12 d | 2026-02-25 |
| Retrospective Acute Care Appendectomy StudyNCT06624215observationalOperative time | — | Recruiting | Procedure: Appendectomy | Acute Appendicitis | 1,000 | 2026-07-31 | — | 2026-04-22 |
| Robotic vs. Open NSM for Early Stage Breast CancerNCT05720039Conversion rateRandomized · Open-label · Treatment | Not applicable | Active, not recruiting | Device: Robotic NSM · Procedure: Open NSM | Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast | 204 | Mar 2026 | — | 2026-02-24 |
| A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBNCT06308120Diagnostic YieldRandomized · Single-masked · Diagnostic | Not applicable | Active, not recruiting | Device: Ion Endoluminal System, superDimension Navigation System and Accessories | Pulmonary Nodule, Solitary, Lung Cancer | 354 | 2025-12-10actual | — | 2026-06-08 |
| da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresNCT04403022results2026-06-03Rate of ConversionNon-randomized · Open-label · OtherStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Robotic Assisted Surgery | Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors | 60 | 2023-09-30actual | — | 2026-06-03 |
| SP Thoracic IDE StudyNCT05150210results2025-12-23Rate of ConversionNon-randomized · Open-label · OtherStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Robotic-Assisted Surgery | Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis | 32 | 2023-06-16actual | — | 2025-12-23 |
| Clinical Investigation of the da Vinci Surgical SystemNCT05682742Incidence of conversionOpen-label · Other | Not applicable | Active, not recruiting | Device: Robotic-assisted Surgery | Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer, Pelvic Organ Prolapse, Prostate Disease, Prostate Cancer, Inguinal Hernia, Ventral Hernia, Obesity, Morbid | 53 | 2023-05-24actual | — | 2024-06-03 |
| ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional LaparoscopyNCT05496244observationalDescribe treatment decision | — | Withdrawnsponsor's stated reason: Overall re-assessment of study design | Device: Laparoscopy, Robotic-assisted surgery | GYN Disorders | 0 | Nov 2026 | ≤ 103 d | 2023-06-15 |
| JURA Study - Observational First-in-human Feasibility StudyNCT07259759observationalImage quality of the JURA System v. 1.0 in humans | — | Completed | Device: Visualization / Imaging | Imaging | 20 | 2026-03-27actual | — | 2026-04-29 |
| Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.NCT06434727observationalClinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning | — | Completed | Other: observational study | Thoracic, Colorectal Disorders | 80 | 2025-11-09actual | — | 2026-03-03 |
| IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological SurgeryNCT05954767Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.Open-label · Prevention | Phase 3 | Completed | Drug: IS-001 | Ureter Injury | 189 | 2025-01-31actual | — | 2026-01-15 |
| Prospective Multi-Center Study of Short-Term Outcomes After Complex CholecystectomyNCT04888117observationalConversion to open | — | Completed | Procedure: Laparoscopic cholecystectomy, Robotic-assisted cholecystectomy | Laparoscopic Cholecystectomy, Robotic-assisted Cholecystectomy | 186 | 2025-01-27actual | — | 2025-05-31 |
| Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTNCT06084208Diagnostic yield of sample(s) obtained (post learning curve)Open-label · Diagnostic | Not applicable | Completed | Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging | Lung Cancer | 132 | 2025-01-24actual | — | 2026-07-15 |
| A Prospective Evaluation of Pain After Non-complex Ventral Hernia RepairNCT04855227observationalChange in pain score assessed by the PROMIS 3a from baseline to 14 days | — | Terminatedsponsor's stated reason: Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements | Procedure: robotic-assisted ventral hernia repair | Ventral Hernia | 69 | 2024-11-04actual | — | 2024-12-19 |
| Early Surgeon Experience With Robotic-Assisted Inguinal Hernia RepairNCT04353687observationalChange of surgeon efficiency | — | Unknown status | Device: Robotic-assisted inguinal hernia repair | Hernia, Inguinal | 6 | 2024-05-31 | — | 2024-03-08 |
| IS-002 Phase 2 Prostate Cancer StudyNCT05946603The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.Randomized · Open-label · Other | Phase 2 | Completed | Drug: Administration of IS-002 · Device: Firefly fluorescent imaging · Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection | Prostate Cancer | 59 | 2024-05-21actual | — | 2025-09-04 |
| InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal ResectionsNCT05973227image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.Open-label · Device feasibility | Not applicable | Completed | Device: use of the TRIDENT system | Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms | 10 | 2024-05-21actual | — | 2024-07-22 |
| Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy SystemNCT05867953Tool in NoduleOpen-label · Diagnostic | Not applicable | Completed | Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging | Lung Cancer | 200 | 2024-04-11actual | — | 2025-09-08 |
| A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal SurgeryNCT05769257Evaluate ureter visualization by Independent ReaderOpen-label · Prevention | Phase 2 | Completed | Drug: IS-001 | Ureter Injury | 12 | 2024-03-18actual | — | 2024-05-29 |
| A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule BiopsyNCT05562895observationalDiagnostic yield | — | Completed | Device: Ion Endoluminal System and Cios Spin | Lung Cancer | 155 | 2023-12-31actual | — | 2025-11-13 |
| Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)NCT04487522observationalPain scores | — | Completed | Procedure: Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair · Device: Robotic-assisted retromuscular ventral hernia repair | Ventral Hernia | 74 | 2023-11-09actual | — | 2024-11-26 |
| Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast ReconstructionNCT05251285observationalNumber of intraoperative R-NSM procedure and device-related complications | — | Terminatedsponsor's stated reason: Low enrolment | Procedure: Nipple-Sparing Mastectomy | Prophylactic Nipple Sparing Mastectomy (NSM) | 7 | 2023-07-18actual | — | 2023-12-22 |
| Pain and Quality of Life After Inguinal Hernia RepairNCT04074200observationalChange in Pain Scores from Baseline to 14 Days | — | Completed | Procedure: Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair · Device: Robotic-Assisted Inguinal Hernia Repair | Inguinal Hernia | 156 | 2023-07-06actual | — | 2024-10-03 |
| A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal SystemNCT05546437observationalSuccessful dye injection | — | Completed | Device: Ion Endoluminal System | Lung Cancer | 288 | 2023-04-30actual | — | 2024-03-08 |
| A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for NephrectomyNCT04329767observationalClinical utility of IRIS 3D model with CT scans during Intra-Operative navigation | — | Completed | Device: IRIS 1.0 | Kidney Cancer | 122 | 2023-02-03actual | — | 2023-09-29 |
| Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical SystemNCT04795817observationalType 1 Polysomnography (PSG) | — | Completed | Device: Transoral Robotic Surgery | Obstructive Sleep Apnea | 25 | 2023-01-25actual | — | 2023-05-31 |
| A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary LesionsNCT05160571observationalDiagnostic yield | — | Completed | Device: Ion Endoluminal System | Lung Cancer, Pulmonary Nodule | 279 | 2022-12-31actual | — | 2023-03-03 |
| Evaluation of Prostate Cancer MarginsNCT05317143observationalPositive Margin | — | Completed | Other: Evaluation of prostate cancer margins | Prostate Cancer | 100 | 2022-11-10actual | — | 2025-04-09 |
| A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia PatientsNCT02715622observationalNumber of complications observed intraoperatively through 30 days | — | Completed | Procedure: Hernia repair | Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia | 944 | Oct 2022actual | — | 2023-03-01 |
| Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical ProceduresNCT05575947observationalIntraoperative Complication Rates (Safety) | — | Completed | Device: da Vinci Surgical System · Procedure: laparoscopic bariatric surgery | Bariatric Surgery Candidate | 1,878 | 2022-09-22actual | — | 2023-09-29 |
| Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body DivergenceNCT04735341observationalIon Catheter Shape | — | Completed | Device: Ion Endoluminal System | Lung Cancer, Pulmonary Nodule, Solitary | 30 | 2022-06-30actual | — | 2022-08-09 |
| Clinical Utility for Ion Endoluminal SystemNCT03893539Navigation SuccessOpen-label · Other | Not applicable | Unknown status | Device: Ion Endoluminal System™ | Pulmonary Nodule, Lung Cancer, Lung Diseases | 365 | 2022-05-26actual | — | 2024-03-29 |
| Prospective Robotic-assisted Revisional Bariatric StudyNCT04506190observationalRate of conversions | — | Completed | Procedure: Revisional bariatric surgery | Bariatric Surgery Candidate | 100 | 2022-03-15actual | — | 2025-04-13 |
| Retrospective Comparison of Lap and Robotic-Assisted RYGB and SGNCT04329780observationalPerioperative complications | — | Completed | — | Bariatric Surgery Candidate | 1,872 | 2022-03-01actual | — | 2025-04-13 |
| Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal AnastomosesNCT03312569observationalIncidence of incisional hernia at one year after index procedure. | — | Completed | Procedure: Right Colectomy with Intracorporeal Anastomosis, Right Colectomy with Extracorporeal Anastomosis | Benign Right Colon Disease, Malignant Right Colon Disease | 306 | 2022-02-14actual | — | 2024-03-12 |
| Open vs Robotic Assisted Partial NephrectomyNCT0384982030 day complicationsRandomized · Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Due to low enrollment the study was terminated | Device: Robotic-assisted partial nephrectomy · Other: Open partial nephrectomy | Renal Cancer | 247 | 2021-12-15actual | — | 2025-06-17 |
| Study of Peri-operative and Acute Outcomes After Robotic-assisted CholecystectomyNCT04551820observationalConversion to open | — | Completed | Procedure: Regular Hours, After Hours · Device: Robotic-assisted Cholecystectomy | Cholecystectomy | 520 | 2021-09-30actual | — | 2021-11-26 |
| A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic ProstatectomyNCT04574401Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0Open-label · Other | Phase 1 | Completed | Drug: IS-002 | Prostate Cancer | 24 | 2021-09-20actual | — | 2021-10-22 |
| A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal ProceduresNCT04247958observationalNumber of SureForm™ Stapler fires and reload colors | — | Completed | Procedure: Colorectal resection | Benign Colon Tumor, Malignant Colorectal Tumor, Benign Colorectal Neoplasm | 60 | 2021-07-21actual | — | 2024-01-05 |
| A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic HysterectomyNCT03937505Evaluate fluorescent intensity of ureter by signal to background analysisNon-randomized · Open-label · Prevention | Phase 2 | Completed | Drug: IS-001, No treatment | Ureter Injury | 94 | 2021-07-08actual | — | 2021-08-05 |
| Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung CancerNCT03347825observationalChart review and data collection of clinical stage IB, IIA, IIB, IIIA cases | — | Completed | Procedure: Robotic-assisted lobectomy using da Vinci Surgical System, VATS (video assisted thoracic surgery), Open lobectomy | Lung Cancer | 7,000 | 2020-07-01actual | — | 2021-02-03 |
| IS-001 Injection Phase-1 Safety, Tolerance and PharmacokineticsNCT03006237Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)Open-label · Diagnostic | Phase 1 | Completed | Drug: IS-001 · Device: da Vinci® Si/Xi Surgical System | Hysterectomy, Surgery | 24 | Dec 2017actual | — | 2018-03-05 |
| Prospective, Multicenter da Vinci® SP™ Surgical System TORS StudyNCT03049280results2020-08-18PerformanceOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Transoral robotic surgery | Oropharyngeal Cancer | 33 | 2017-11-14actual | — | 2020-10-06 |
| Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right ColectomyNCT03019016observationalChart review on PeriOperative Information | — | Completed | Procedure: Right Colectomy | Colonic Neoplasms, Crohn Disease | 1,000 | Sep 2017actual | — | 2017-10-26 |
| Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic CholecystectomyNCT01932216CosmesisRandomized · Open-label · Treatment | Not applicable | Completed | Procedure: Cholecystectomy | Symptomatic Gallbladder Disease | 136 | Dec 2016actual | — | 2017-10-16 |
| Robotic-assisted Versus Laparoscopic Sigmoid ResectionNCT02636673observationalNumber of complications observed intraoperatively through 30-days | — | Completed | Procedure: Sigmoid Resection | Sigmoid Diseases | 518 | Jul 2016actual | — | 2016-08-30 |
| Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia RepairNCT02684448observationalNumber of complications observed intraoperatively through 30-days | — | Completed | Procedure: Inguinal Hernia Repair | Hernia, Inguinal, Hernia, Inguinal, Direct, Hernia, Inguinal, Indirect | 1,258 | Jun 2016actual | — | 2017-03-28 |
| A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS ProceduresNCT02002845observationalPrimary Effectiveness Endpoint | — | Completed | Device: robotic surgery using the da Vinci Surgical System | Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System | 285 | Feb 2014actual | — | 2015-12-10 |
| Prospective Investigation of Robotic Single-port SystemNCT02136121To determine the feasibility as measured by the rate of conversionsOpen-label | Phase 1/2 | Completed | Device: da Vinci Sp Surgical System - Robotic | Prostate and Kidney Cancer | 19 | Oct 2013actual | — | 2014-05-12 |
| Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)NCT01410734To identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).Non-randomized · Open-label · Diagnostic | Not applicable | Completed | Drug: Indocyanine green (ICG) | Gallbladder Disease, Biliary Colic, Gallstones | 72 | Dec 2012actual | — | 2012-12-20 |
| Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared ImagingNCT01104389The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.Non-randomized · Open-label | Not applicable | Withdrawnsponsor's stated reason: Study was never started | Device: Fluorescence imaging | Renal Tumors | 0 | Jul 2010 | — | 2015-08-26 |
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