Appendicitis AcuteNCT07455487
First Appendectomy Using Revolve Surgical Robotic Arm
A study testing Revolve Surgical System - RSS in people with Appendicitis Acute, run by Unity Health Toronto.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Revolve Surgical System - RSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Appendicitis Acute
- Being tested
- Revolve Surgical System - RSS
- Keywords
- Robotics, Appendicitis, Laparoscopy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revolve Surgical System - RSSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Revolve Surgical System - RSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (from skin incision to completion of surgery)
Secondary outcomes (1)
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.
Measured: Immediately post-procedure (same operative day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Revolve Surgical Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455487
- Sponsor's protocol ID
- 25-235
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Appendectomy Using Revolve Surgical Robotic Arm
- ClinicalTrials.gov ID
- NCT07455487
- Acronym / sponsor ID
- 25-235
- Conditions
- Appendicitis Acute
- Keywords
- Robotics, Appendicitis, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Revolve Surgical Inc.
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Revolve Surgical System - RSSParticipants 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 |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revolve Surgical System - RSSParticipants 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 | Device | Interventional Arm |
Primary outcome
Successful Completion of Appendectomy Using RSS Without Conversion
Time frame: Intraoperative (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.
1 secondary outcome
System Usability Scale (SUS) Score
Time frame: Immediately post-procedure (same operative day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Revolve Surgical System - RSS in people with Appendicitis Acute, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joao Rezende-Neto, MD ((416) 864-5284, Joao.Rezende-Neto@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Completion of Appendectomy Using RSS Without Conversion (time frame: Intraoperative (from skin incision to completion of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.