An interventional study of Revolve Surgical System - RSS in Appendicitis Acute, sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 3 is below the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Jul 2026, 3 months later.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 3 months is below that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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