A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
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
1 other identifier
observational
200
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
February 25, 2026
October 1, 2025
1.2 years
March 11, 2025
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the force imparted on the tissue by force feedback instruments.
Intra-operative
Secondary Outcomes (1)
To evaluate the utility of force feedback instruments during specific procedural steps or tasks.
Post-operative prior to discharge
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Miami
Miami, Florida, 33136, United States
Northeast Georgia Medical Center, Inc
Gainesville, Georgia, 30501, United States
Northwestern Memorial Healthcare
Chicago, Illinois, 60611, United States
Ohio State University
Columbus, Ohio, 43210, United States
St. David's Healthcare
Austin, Texas, 78758, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 17, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
February 25, 2026
Record last verified: 2025-10