First Appendectomy Using Revolve Surgical Robotic Arm

NCT07455487 | Not Yet Recruiting

• 1 other identifier: 25-235
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Appendicitis Acute

Keywords

Robotics; Appendicitis; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Successful Completion of Appendectomy Using RSS Without Conversion

  Number and proportion of participants in whom appendectomy is completed using the Revolve Surgical System (RSS) without removal for conventional laparoscopic or open appendectomy.

  Intraoperative (from skin incision to completion of surgery)

Secondary Outcomes (1)

• System Usability Scale (SUS) Score

  Immediately post-procedure (same operative day)

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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 ca

Device: Revolve Surgical System - RSS

Interventions

Revolve Surgical System - RSS DEVICE

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

Interventional Arm

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Inpatients at Unity Health Toronto - St. Michael's Hospital scheduled for an elective appendectomy
• Ages of 21-40 years old
• Male and non-pregnant female patients (pregnancy test required)
• No co-morbidities
• Body Mass Index (BMI) between 18.5 and 25kg/m2
• On no medications
• Not taking any recreational drugs
• Uncomplicated acute appendicitis (confirmed through abdominal ultrasound or abdominal computed tomography (CT) scan)
• The pre-operative white blood cell count (WBC) must be between 4,500 - 15,000 cells per microliter.

You may not qualify if:

• Imaging of perforated appendix, free air, phlegmon, abscess, fluid collection, other any abdominal disease.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Revolve Surgical Inc.: collaborator

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Joao Rezende-Neto, MD

CONTACT

(416) 864-5284; Joao.Rezende-Neto@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share