Status:
RECRUITING
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
Lead Sponsor:
Intuitive Surgical
Conditions:
Hernia, Inguinal
Hernia, Ventral
Eligibility:
All Genders
22+ years
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.
Eligibility Criteria
Inclusion
- Pre-Operative
- 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
- 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.
Key Trial Info
Start Date :
May 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06879912
Start Date
May 22 2025
End Date
August 1 2026
Last Update
October 16 2025
Active Locations (2)
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1
Ohio State University
Columbus, Ohio, United States, 43210
2
St. David's Healthcare
Austin, Texas, United States, 78758