A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

Last updated: February 23, 2026
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT06879912
ISI-dV5-MP-01
  • Ages > 22
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 surgerywith da Vinci 5 with Force Feedback instruments for the study specified procedure asprimary procedure prior to enrollment in the study

  4. Subject or a legally authorized representative is able to provide written informedconsent using the study informed consent form prior to the study

  5. Subject is willing and able to comply with the study protocol requirements includingfollow up schedule

Exclusion

Pre-operative Exclusion Criteria:

  • Subject receiving an emergent procedure

  • Subject planned to undergo major concomitant surgery for the treatment of adifferent medical condition than was originally planned

  • Subject with previous ipsilateral surgery (open, endoscopic or robotic) with thesame surgical indication

  • Subject with past or ongoing medical conditions (for example: inflammatory boweldisease) which, in the judgment of the Investigator, puts them at high risk forsurgery 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 ofthe Investigator, might interfere with the collection of complete quality data

  • Subject is currently participating in or has participated in a study of aninvestigational agent or a significant risk investigational device study within thepast 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 thepast 6 months

Intra-operative Exclusion Criteria

  • Subject with hemodynamic or respiratory instability, which precludes theInvestigator from performing the RAS.

  • Subject in whom inadequate visualization makes a minimally invasive approach notfeasible, as determined from the investigator assessment prior to docking the robot.

  • Subject with adhesions, scarring and disease status in the body which in the opinionof the investigator limits the ability to perform the minimally invasive procedure.

Study Design

Total Participants: 200
Study Start date:
May 22, 2025
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center, Inc

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Active - Recruiting

  • Northwestern Memorial Healthcare

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • St. David's Healthcare

    Austin 4671654, Texas 4736286 78758
    United States

    Active - Recruiting

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