[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":20,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nThe 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.\n\nThe 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",[13],"Device: Revolve Surgical System - RSS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.\n\nThe 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.\n\nThe 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",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Joao Rezende-Neto, MD","CONTACT","(416) 864-5284","Joao.Rezende-Neto@unityhealth.to",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[30],{"name":31,"class":32},"Revolve Surgical Inc.","UNKNOWN","100627965","first-appendectomy-using-revolve-surgical-robotic-arm-100627965",false,"NCT07455487","First Appendectomy Using Revolve Surgical Robotic Arm","Inclusion Criteria:\n\n* Inpatients at Unity Health Toronto - St. Michael's Hospital scheduled for an elective appendectomy\n* Ages of 21-40 years old\n* Male and non-pregnant female patients (pregnancy test required)\n* No co-morbidities\n* Body Mass Index (BMI) between 18.5 and 25kg\u002Fm2\n* On no medications\n* Not taking any recreational drugs\n* Uncomplicated acute appendicitis (confirmed through abdominal ultrasound or abdominal computed tomography (CT) scan)\n* The pre-operative white blood cell count (WBC) must be between 4,500 - 15,000 cells per microliter.\n\nExclusion Criteria:\n\n* Any patient who does not have all the inclusion criteria described above.\n* Imaging of perforated appendix, free air, phlegmon, abscess, fluid collection, other any abdominal disease.\n* Any other abnormal laboratory test performed pre-operatively will cause the exclusion of the patient from the study.","ALL","21 Years","40 Years",{"count":43,"type":44},3,"ESTIMATED","INTERVENTIONAL",[47],"NA","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.\n\nThis 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.",[50],"Appendicitis Acute",[52,53,54],"Robotics","Appendicitis","Laparoscopy","NOT_YET_RECRUITING","2026-03-02",{"date":58,"type":59},"2026-03-06","ACTUAL",{"date":61,"type":44},"2026-04-01",{"date":63,"type":44},"2027-01-01",{"name":5,"class":6}]