Clinical trials: sponsored by Intuitive Surgical
DIEP Flap Breast Reconstruction
Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction.
- Trial name
- (DIEP) (NCT07222514)
- Testing
- Single-Port Robotic System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University Medical Center
Imaging
JURA Study - Observational First-in-human Feasibility Study
Evaluate the functionality of the JURA System v. 1.0
- Trial name
- JURA (NCT07259759)
- Testing
- Visualization / Imaging
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Intuitive Surgical
Lung Cancer, Multiple Pulmonary Nodules
Real World Registry for Use of the Ion Endoluminal System
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
- Conditions
- Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms
- Trial name
- NCT06004440
- Testing
- Ion Endoluminal System
- Where
- 16 sites in United States
- Volunteers
- 1,301 people
- Sponsor
- Intuitive Surgical
Nipple Sparing Mastectomy
Open Nipple Sparing Mastectomy (NSM)
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
- Trial name
- NSM Open (NCT04447339)
- Testing
- Nipple Sparing Mastectomy
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Intuitive Surgical
Thoracic, Colorectal Disorders
Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy…
- Trial name
- ISI-I3DM-01 (NCT06434727)
- Testing
- observational study
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Intuitive Surgical
Breast Cancer Female, Breast Cancer
Robotic vs. Open NSM for Early Stage Breast Cancer
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease
- Trial name
- SP NSM (NCT05720039)
- Testing
- Robotic NSM, Open NSM
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Intuitive Surgical
Ureter Injury
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
- Trial name
- NCT05954767
- Testing
- IS-001
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- Intuitive Surgical
Pancreatic Adenocarcinoma, Pancreatic Cysts
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors
This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.
- Conditions
- Pancreatic Adenocarcinoma, Pancreatic Cysts, Pancreatic Endocrine Tumors, Chronic Pancreatitis
- Trial name
- PORTAL (NCT04400357)
- Testing
- Robotic pancreaticoduodenectomy, Open pancreaticoduodenectomy
- Where
- China
- Volunteers
- 268 people
- Sponsor
- Ruijin Hospital
Nipple Sparing Mastectomy
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
- Trial name
- NCT03892980
- Testing
- Nipple-Sparing Mastectomy
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Intuitive Surgical
Lung Cancer
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
- Trial name
- NCT05562895
- Testing
- Ion Endoluminal System and Cios Spin
- Where
- 6 sites in United States
- Volunteers
- 155 people
- Sponsor
- Intuitive Surgical
Right Sided Colon Cancer, Right Colectomy
Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen
Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved.
- Conditions
- Right Sided Colon Cancer, Right Colectomy, Lymphadenectomy
- Trial name
- RCC (NCT06329102)
- Testing
- Surgical access
- Where
- Norway
- Volunteers
- 1,000 people
- Sponsor
- Haukeland University Hospital
Lung Cancer
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans.
- Trial name
- NCT05867953
- Testing
- Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Intuitive Surgical
Prostate Cancer
IS-002 Phase 2 Prostate Cancer Study
Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended)…
- Trial name
- NCT05946603
- Testing
- Administration of IS-002, Firefly fluorescent imaging, robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
- Where
- 4 sites in United States
- Volunteers
- 59 people
- Sponsor
- Intuitive Surgical
Renal Cancer
Open vs Robotic Assisted Partial Nephrectomy
To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high…
- Trial name
- OpeRa (NCT03849820)
- Testing
- Robotic-assisted partial nephrectomy, Open partial nephrectomy
- Where
- 12 sites in Germany
- Volunteers
- 247 people
- Sponsor
- Intuitive Surgical
Laparoscopic Cholecystectomy, Robotic-assisted Cholecystectomy
Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.
- Trial name
- NCT04888117
- Testing
- Laparoscopic cholecystectomy, Robotic-assisted cholecystectomy
- Where
- 4 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Intuitive Surgical
Upper Tract Urothelial Cancer
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
- Trial name
- NCT06987552
- Testing
- Da Vinci SP Surgical System
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- National Taiwan University Hospital
Bariatric Surgery Candidate
Prospective Robotic-assisted Revisional Bariatric Study
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing…
- Trial name
- NCT04506190
- Testing
- Revisional bariatric surgery
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Intuitive Surgical
Bariatric Surgery Candidate
Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG
A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
- Trial name
- NCT04329780
- Where
- United States
- Volunteers
- 1,872 people
- Sponsor
- Intuitive Surgical
Prostate Cancer
Evaluation of Prostate Cancer Margins
Pathological assessment of prostate tissue
- Trial name
- NCT05317143
- Testing
- Evaluation of prostate cancer margins
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Intuitive Surgical
Rectal Cancer
Rectal Surgery Evaluation Trial (RESET)
Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer.
- Trial name
- RESET (NCT03574493)
- Testing
- TME with LAR
- Where
- France
- Volunteers
- 1,098 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle