[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615183":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"CMR Surgical Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery with Versius","EXPERIMENTAL",null,[13],"Device: Versius Surgical System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"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",[9],[21],{"name":22,"affiliation":23,"role":24},"Krzysztof Nowosielski, MD","Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Mark Slack, MD","CONTACT","+44 7766 024389","mark.slack@cmrsurgical.com",{"name":32,"role":28,"phone":11,"phoneExt":11,"email":33},"Chad Schaber, PhD","chad.schaber@cmrsurgical.com",[35],{"facility":23,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Katowice","40-572","Poland","PL",{"type":42,"coordinates":43},"Point",[44,45],19.02173,50.2597,{"lat":45,"lon":44},[48,52],{"name":49,"role":28,"phone":50,"phoneExt":11,"email":51},"Main contact","+32 7894726","knowosielski@sum.edu.pl",{"name":22,"role":24,"phone":11,"phoneExt":11,"email":11},{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[56],{"name":23,"class":57},"UNKNOWN","100615183","versius-gynecology-study-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":68,"type":69},45,"ESTIMATED","INTERVENTIONAL",[72],"NA","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",[75],"Robotic Assisted Hysterectomy and\u002For Salpingo-oophorectomy",[77,78,79,80,81],"Versius","robotic surgery","hysterectomy","salpingo-oophrectomy","gynecology","2025-12-04",{"date":84,"type":85},"2025-12-17","ACTUAL",{"date":87,"type":85},"2025-07-25",{"date":89,"type":69},"2026-01",{"name":5,"class":6},1]