Clinical Investigation of the da Vinci Surgical System

NCT05682742 · tracked via the Priya Life Science USA tracker

Sponsor

Intuitive Surgical

Phase

Not applicable

Started

2022-12-12

Last updated

2024-06-03

Condition(s) studied

ThymomaMediastinal TumorGynecologic DiseaseGynecologic CancerPelvic Organ ProlapseProstate DiseaseProstate CancerInguinal HerniaVentral HerniaObesity, Morbid

Investigational drug(s) / intervention(s)

Robotic-assisted Surgery

Robotic-assisted Surgery: Subjects scheduled to undergo robotic-assisted surgery

Study summary

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Eligibility

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

Pre-operative Inclusion Criteria: * Age 21 years or older * Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure Pre-operative Exclusion Criteria: * Subject is pregnant or suspected to be pregnant or breastfeeding * Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data * Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months * Subject belongs to vulnerable population. * Subject is contraindicated for anesthesia or surgery * Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months

Primary outcome measure(s)

Incidence of conversion — Intra-operative
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Trial sites (4)

Facility	City	Region
Orlando Health, Inc.	Orlando	Florida
Sparrow Health System	Lansing	Michigan
The Valley Hospital	Ridgewood	New Jersey
The Ohio State University Wexner Medical Center	Columbus	Ohio

More Intuitive Surgical trials in the USA

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy Active, not recruiting

Open Nipple Sparing Mastectomy (NSM) Active, not recruiting

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot Active, not recruiting

SP Thoracic IDE Study Active, not recruiting

Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05682742 on ClinicalTrials.gov ↗ ← All trials in the USA