Clinical trials: sponsored by Intuitive Surgical
Pulmonary Nodule, Lung Cancer
European Real-World Registry for Use of the Ion Endoluminal System
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
- Trial name
- NCT06923774
- Testing
- Ion endoluminal system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Intuitive Surgical
Lung Cancer (Diagnosis)
Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign
The goal of this observational study is to learn about the diagnostic performance and safety of robotic-assisted bronchoscopy using the Ion Endoluminal System in adults with small lung nodules that do not show a bronchus sign on…
- Trial name
- NCT07862816
- Where
- 4 sites in South Korea
- Volunteers
- 151 people
- Sponsor
- Intuitive Surgical
Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
- Trial name
- NCT04403022
- Testing
- Robotic Assisted Surgery
- Where
- 9 sites in United States, South Korea
- Volunteers
- 60 people
- Sponsor
- Intuitive Surgical
Lung Cancer (Diagnosis), Lung Nodule
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and…
- Trial name
- ENCOMPASS (NCT07761351)
- Testing
- Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT), CT-guided percutaneous lung nodule biopsy
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 550 people
- Sponsor
- Intuitive Surgical
Acute Appendicitis
Retrospective Acute Care Appendectomy Study
The purpose of this retrospective study is to compare perioperative data for subjects who have undergone an emergent or urgent robotic-assisted or laparoscopic appendectomy for acute appendicitis.
- Trial name
- NCT06624215
- Testing
- Appendectomy
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Intuitive Surgical
Prostate Cancer
CoSMAP Trial: SP-EA vs MP-TA Robot-Assisted Radical Prostatectomy
This multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in…
- Trial name
- CoSMAP (NCT07666217)
- Where
- 8 sites in Japan
- Volunteers
- 625 people
- Sponsor
- Intuitive Surgical
Lung Cancer
Lung cAncer Robotic Comparative Study
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
- Trial name
- LARCS (NCT06038227)
- Testing
- Robotic Assisted Thoracic Surgery, Video Assisted Thoracic Surgery
- Where
- 13 sites in Denmark, France and 5 more
- Volunteers
- 600 people
- Sponsor
- Intuitive Surgical
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Primary Lung Cancer, Benign Lung Disease
SP Thoracic IDE Study
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
- Conditions
- Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
- Trial name
- NCT05150210
- Testing
- Robotic-Assisted Surgery
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Intuitive Surgical
GYN Disorders
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German…
- Trial name
- GENERATE (NCT05867927)
- Testing
- Robotic-assisted surgery (da Vinci), Non-da Vinci Surgery
- Where
- 15 sites in Germany
- Volunteers
- 1,250 people
- Sponsor
- Intuitive Surgical
Cholecystectomy
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.
- Trial name
- SPARC (NCT04551820)
- Testing
- Regular Hours, After Hours, Robotic-assisted Cholecystectomy
- Where
- United States
- Volunteers
- 505 people
- Sponsor
- Intuitive Surgical
Hernia, Inguinal, Hernia, Ventral
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic
- Trial name
- NCT06879912
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Intuitive Surgical
Ureter Injury
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
- Trial name
- NCT07346066
- Testing
- filricianine
- Where
- 9 sites in United States
- Volunteers
- 146 people
- Sponsor
- Intuitive Surgical
Lung Cancer
Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT
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
- NCT06084208
- Testing
- Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
- Where
- Netherlands
- Volunteers
- 132 people
- Sponsor
- Intuitive Surgical
Pulmonary Nodule, Solitary, Lung Cancer
A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral…
- Trial name
- ARTICULAtE (NCT06308120)
- Testing
- Ion Endoluminal System, superDimension Navigation System and Accessories
- Where
- 3 sites in China
- Volunteers
- 354 people
- Sponsor
- Intuitive Surgical
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