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NOT YET RECRUITING
NCT07455487
NA

First Appendectomy Using Revolve Surgical Robotic Arm

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

Summary

This study is testing a new surgical device called the Revolve Surgical System (RSS) during appendix removal surgery. The RSS is designed to help surgeons perform minimally invasive surgery with improved precision and stability while working at the patient's bedside, similar to standard laparoscopic surgery but with robotic assistance. This will be the first time the device is used in patients. It will be evaluated in three adults with uncomplicated appendicitis who are already scheduled to have an appendectomy. The purpose of the study is to assess whether the device can be used safely and effectively and to better understand how it performs during surgery.

Key Details

Gender

All

Age Range

21 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2026-04-01

Completion Date

2027-01-01

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DEVICE

Revolve Surgical System - RSS

Participants in this single study arm will undergo a standard laparoscopic appendectomy with the assistance of the investigational Revolve Surgical System (RSS). The RSS is a bedside robotic support device designed to stabilize and position the laparoscopic camera and surgical instruments under the direct control of the operating surgeon. The intervention involves using the RSS to hold and guide selected instruments during surgery in a stepwise manner. In the first case, the device will support the laparoscopic camera only. In the second case, it will support the camera and one working instrument. In the third case, it will support the camera and two working instruments. All other surgical steps will follow standard laparoscopic appendectomy techniques. The surgeon remains at the patient's bedside at all times and can immediately disengage and remove the device if needed. Standard laparoscopic instruments and equipment will be available throughout the procedure, and the operation can