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

September 1, 2026 updated by: Intuitive Surgical

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92123
    - Sharp Memorial Hospital
- Florida
  - Miami, Florida, United States, 33136
    - University of Miami
- Georgia
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center, Inc
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Healthcare
- Ohio
  - Columbus, Ohio, United States, 43210
    - Ohio State University
- Texas
  - Austin, Texas, United States, 78758
    - St. David's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Subjects who will undergo the study specified procedure as primary procedure with da Vinci 5 robot and who meet all eligibility criteria will be considered for enrollment.

Description

Pre-Operative Inclusion Criteria:

Age 22 years or older
ASA ≤ 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
Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the force imparted on the tissue by force feedback instruments. Time Frame: Intra-operative	Intra-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the utility of force feedback instruments during specific procedural steps or tasks. Time Frame: Post-operative prior to discharge	Post-operative prior to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2025

Primary Completion (Actual)

August 19, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria