[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615183":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":56,"studyPopulation":56,"armGroups":67,"interventions":73,"overallOfficials":79,"centralContacts":84,"locations":93,"responsibleParty":112,"collaborators":114,"id":117,"slug":56,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":56,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":56,"enrollmentInfo":125,"targetDuration":56,"studyType":128,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":95,"whyStopped":56,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"CMR Surgical Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":56},[9,13],{"measure":10,"description":11,"timeFrame":12},"Success rate","Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.","Day of surgery",{"measure":14,"description":15,"timeFrame":16},"Serious Adverse Event rate","Rate of total serious adverse events","Up to 30 days post procedure",[18,21,24,27,31,34,37,41,44,48,51,54,57],{"measure":19,"description":20,"timeFrame":12},"Operative time","Surgical time from skin incision to skin closure",{"measure":22,"description":23,"timeFrame":12},"Estimated blood loss","Amount of blood estimated to be lost during surgery (in mL)",{"measure":25,"description":26,"timeFrame":12},"Intra-operative complications","Complications that occur during surgery",{"measure":28,"description":29,"timeFrame":30},"Blood transfusions","Need for blood transfusion during or after surgery as well as amount transfused","Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days",{"measure":32,"description":33,"timeFrame":12},"Unplanned instrument use","Whether unplanned use of non-Versius laparoscopic instruments during surgery occurs as well as at what surgical step",{"measure":35,"description":36,"timeFrame":12},"Device deficiencies","Any device deficiencies of Versius during surgery",{"measure":38,"description":39,"timeFrame":40},"Reoperation within 24 hours","Need for reoperation after initial surgery","24 hours post-surgery",{"measure":42,"description":43,"timeFrame":30},"Length of hospital stay","Hospital stay in days from day of surgery until discharge",{"measure":45,"description":46,"timeFrame":47},"Adverse events","Rate of adverse events","Up to 30 days post-surgery",{"measure":49,"description":50,"timeFrame":47},"Readmission","Hospital readmission after post-surgical discharge",{"measure":52,"description":53,"timeFrame":47},"Reoperation within 30 days","Need for reoperation as a result of interventional surgery itself or the indication for surgery",{"measure":55,"description":56,"timeFrame":47},"Mortality rate",null,{"measure":58,"description":59,"timeFrame":60},"Vaginal vault healing","Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy","42 days post-surgery",{"allocation":62,"interventionModel":63,"interventionModelDescription":56,"primaryPurpose":64,"observationalModel":56,"timePerspective":56,"maskingInfo":65},"NA","SINGLE_GROUP","TREATMENT",{"masking":66,"maskingDescription":56,"whoMasked":56},"NONE",[68],{"label":69,"type":70,"description":56,"interventionNames":71},"Surgery with Versius","EXPERIMENTAL",[72],"Device: Versius Surgical System",[74],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":56},"DEVICE","Versius Surgical System","Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures",[69],[80],{"name":81,"affiliation":82,"role":83},"Krzysztof Nowosielski, MD","Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":56,"email":89},"Mark Slack, MD","CONTACT","+44 7766 024389","mark.slack@cmrsurgical.com",{"name":91,"role":87,"phone":56,"phoneExt":56,"email":92},"Chad Schaber, PhD","chad.schaber@cmrsurgical.com",[94],{"facility":82,"status":95,"city":96,"state":56,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"RECRUITING","Katowice","40-572","Poland","PL",{"type":101,"coordinates":102},"Point",[103,104],19.02173,50.2597,{"lat":104,"lon":103},[107,111],{"name":108,"role":87,"phone":109,"phoneExt":56,"email":110},"Main contact","+32 7894726","knowosielski@sum.edu.pl",{"name":81,"role":83,"phone":56,"phoneExt":56,"email":56},{"type":113,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR",[115],{"name":82,"class":116},"UNKNOWN","100615183",false,"NCT07289295","Versius Gynecology Study","Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy","Inclusion Criteria:\n\n1. Female, aged 22 years or above, who provided written informed consent to participate in the study.\n2. Patient deemed suitable for minimally invasive total hysterectomy and\u002For Salpingo-Oophorectomy, for benign condition.\n3. Patient with BMI ≤40.\n\nExclusion Criteria:\n\n1. Patient unwilling to provide informed consent.\n2. Medical contraindication for general anaesthesia or minimally invasive procedure.\n3. Oncological cases, patient undergoing surgery or treatment for malignant disease.\n4. Clinically assessed Uterus size of \\> 14 pregnancy weeks (Estimated as \\> 14-15 cm longitudinal diameter).\n5. Patient participation in an interventional clinical study that could impact primary outcomes results.\n6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).\n7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.","FEMALE","22 Years",{"count":126,"type":127},45,"ESTIMATED","INTERVENTIONAL",[62],"The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and\u002For salpingo-oophorectomy",[132],"Robotic Assisted Hysterectomy and\u002For Salpingo-oophorectomy",[134,135,136,137,138],"Versius","robotic surgery","hysterectomy","salpingo-oophrectomy","gynecology","2025-12-04",{"date":141,"type":142},"2025-12-17","ACTUAL",{"date":144,"type":142},"2025-07-25",{"date":146,"type":127},"2026-01",{"name":5,"class":6},1]