First Appendectomy Using Revolve Surgical Robotic Arm

ConditionAppendicitis Acute

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-40

SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any patient who does not have all the inclusion criteria described above.

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

Any other abnormal laboratory test performed pre-operatively will cause the exclusion of the patient from the study.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

3 Participants

are divided into 1 treatment group

Group A: Interventional ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Intraoperative (from skin incision to completion of surgery)

Secondary outcomes

System Usability Scale (SUS) Score

Mean total System Usability Scale (SUS) score (range 0-100) completed by three observing surgeons immediately following the procedure. Higher scores indicate greater perceived usability of the Revolve Surgical System.

Time frame

Immediately post-procedure (same operative day)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Revolve Surgical Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: