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First Appendectomy Using Revolve Surgical Robotic Arm

First Appendectomy Using Revolve Surgical Robotic Arm

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07455487
Enrollment
3
Registered
2026-03-06
Start date
2026-04-01
Completion date
2027-01-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis Acute

Keywords

Robotics, Appendicitis, Laparoscopy

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.

Detailed description

This study is testing a new Canadian surgical device called the Revolve Surgical System (RSS) during minimally invasive appendix removal surgery (appendectomy). The RSS is a small robotic support arm that helps the surgeon hold and control the camera and surgical instruments more steadily. It is designed to reduce hand tremor, improve precision, and decrease the need for extra assistants, while allowing the surgeon to remain beside the patient rather than operating from a remote console. This will be the first time the RSS is used in human patients. Because of this, the main goal of the study is to make sure the device can be used safely and effectively during a routine operation. The study will include three adult patients with uncomplicated appendicitis who are already scheduled for a standard laparoscopic appendectomy. The study will be done in a gradual, step-by-step way. In the first patient, the RSS will only hold the camera. In the second, it will hold the camera and one instrument. In the third, it will hold the camera and two instruments. This careful approach allows the surgical team to evaluate safety before increasing how much the device is used. All other aspects of care will be the same as standard treatment. Patients will receive routine anesthesia, monitoring, and post-operative care. If the device does not function as expected at any time, it can be quickly removed, and the surgeon will immediately continue the operation using standard laparoscopic or open surgical techniques. Backup equipment will always be ready. Researchers will record information such as setup time, length of surgery, any need to switch back to standard methods, and whether any device issues occur. Usual recovery information and any complications will also be tracked. Surgeons and patients may be asked to complete short feedback questionnaires. There may be no direct benefit to participants, but the study could help improve future surgical care by making advanced minimally invasive technology more accessible and efficient. Findings from this pilot study will guide decisions about larger future studies.

Interventions

DEVICERevolve 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

Sponsors

Unity Health Toronto
Lead SponsorOTHER
Revolve Surgical Inc.
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Successful Completion of Appendectomy Using RSS Without ConversionIntraoperative (from skin incision to completion of surgery)Number and proportion of participants in whom appendectomy is completed using the Revolve Surgical System (RSS) without removal for conventional laparoscopic or open appendectomy.

Secondary

MeasureTime frameDescription
System Usability Scale (SUS) ScoreImmediately post-procedure (same operative day)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.

Contacts

CONTACTJoao Rezende-Neto, MD
Joao.Rezende-Neto@unityhealth.to(416) 864-5284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026