Force-feedback instruments with the da Vinci 5 robotic system
A Prospective, Post-Market Study to Evaluate the Clinical Utility of the Force Feedback Instruments in RAS Procedures Using the da Vinci 5 Surgical System
Intuitive Surgical · NCT06879912
We will try force‑feedback instruments on the da Vinci 5 robot during multi‑port robotic surgeries in adults (22+) having hernia, colorectal, thoracic, or gynecologic procedures to see if they help during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Intuitive Surgical (industry) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 5 sites (Miami, Florida and 4 other locations) |
| Trial ID | NCT06879912 on ClinicalTrials.gov |
What this trial studies
This is an observational study that collects information from adults undergoing planned multi‑port procedures using the da Vinci 5 robot with force‑feedback instruments. Enrolled patients are age 22 or older with ASA class ≤3 and will have the force‑feedback instruments used as the primary approach for their planned procedure. Investigators will record perioperative data, procedural characteristics, safety events, and surgeon feedback to characterize how the instruments perform in routine clinical use. Emergency cases, patients with prior ipsilateral surgery for the same indication, and those requiring major additional surgery are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults 22 or older with ASA class 3 or better who are scheduled for a planned multi‑port robotic procedure with the da Vinci 5 using force‑feedback instruments and can provide informed consent.
Not a fit: Patients undergoing emergency operations, those with prior ipsilateral surgery for the same indication, or those with major concomitant surgical needs or certain active medical conditions may not be eligible or likely to benefit from the approach.
Why it matters
Potential benefit: If successful, force‑feedback instruments may give surgeons better tactile information and control during robotic procedures, which could reduce complications and improve surgical precision.
How similar studies have performed: Haptic and force‑feedback technologies in robotic surgery are an emerging area with encouraging preclinical and small clinical reports, but broader clinical benefit has not yet been definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Pre-Operative Inclusion Criteria: 1. Age 22 years or older 2. ASA ≤ 3 3. The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study 4. Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study 5. Subject is willing and able to comply with the study protocol requirements including follow up schedule Pre-operative Exclusion Criteria: * Subject receiving an emergent procedure * Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned * Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication * Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study * 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 a vulnerable population. * Subject is contraindicated for anesthesia or surgery. * Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for the treatment of the cancer to be resected within the past 6 months Intra-operative Exclusion Criteria * Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS. * Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot. * Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.
Where this trial is running
Miami, Florida and 4 other locations
- University of Miami — Miami, Florida, United States (RECRUITING)
- Northeast Georgia Medical Center, Inc — Gainesville, Georgia, United States (RECRUITING)
- Northwestern Memorial Healthcare — Chicago, Illinois, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
- St. David's Healthcare — Austin, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Smruthi Srinivasa Murthy
- Email: smruthi.srinivasamurthy@intusurg.com
- Phone: 682-552-6131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic, Gynecologic, Partial Nephrectomy