[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617276":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":66,"overallOfficials":72,"centralContacts":77,"locations":86,"responsibleParty":99,"collaborators":101,"id":104,"slug":53,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":53,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":53,"enrollmentInfo":112,"targetDuration":53,"studyType":115,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":124,"whyStopped":53,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"CMR Surgical Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":53},[9,13],{"measure":10,"description":11,"timeFrame":12},"Success rate","Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery","Up to completion of surgery",{"measure":14,"description":15,"timeFrame":16},"Serious Adverse Event rate","Rate of total procedure related serious adverse events","Up to 30 days post procedure",[18,21,24,27,30,33,37,41,45,48,51],{"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 adverse events","Adverse events that occur during surgery",{"measure":28,"description":29,"timeFrame":12},"Blood transfusion","Need for blood transfusion during surgery as well as amount transfused",{"measure":31,"description":32,"timeFrame":12},"Device deficiencies","Any device deficiencies of Versius during surgery",{"measure":34,"description":35,"timeFrame":36},"Reoperation within 24 hours","Need for reoperation after initial surgery","24 hours post-surgery",{"measure":38,"description":39,"timeFrame":40},"Length of hospital stay","Hospital stay in days from day of surgery until discharge","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":42,"description":43,"timeFrame":44},"Adverse events","Rate of adverse events","Up to 30 days post-surgery",{"measure":46,"description":47,"timeFrame":44},"Readmission","Hospital readmission after post-surgical discharge",{"measure":49,"description":50,"timeFrame":44},"Reoperation within 30 days","Need for reoperation as a result of interventional surgery itself or the indication for surgery",{"measure":52,"description":53,"timeFrame":44},"Mortality rate",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"NA","SINGLE_GROUP","TREATMENT",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE",[61],{"label":62,"type":63,"description":53,"interventionNames":64},"Surgery with Versius","EXPERIMENTAL",[65],"Device: Versius Surgical System",[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":53},"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.",[62],[73],{"name":74,"affiliation":75,"role":76},"Bruno Domenico Antonio Alampi, MD","Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":53,"email":82},"Mark Slack, MD","CONTACT","+44 7766 024389","mark.slack@cmrsurgical.com",{"name":84,"role":80,"phone":53,"phoneExt":53,"email":85},"Chad Schaber, PhD","chad.schaber@cmrsurgical.com",[87],{"facility":75,"status":53,"city":88,"state":53,"zip":53,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Milan","Italy","IT",{"type":92,"coordinates":93},"Point",[94,95],12.59836,42.78235,{"lat":95,"lon":94},[98],{"name":74,"role":76,"phone":53,"phoneExt":53,"email":53},{"type":100,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[102],{"name":75,"class":103},"UNKNOWN","100617276",false,"NCT07316517","Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery","Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Inguinal Hernia Repair Surgery","Inclusion Criteria:\n\n1. Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.\n2. Patients providing written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patient unwilling to provide informed consent.\n2. Medical contraindication for general anaesthesia or minimally invasive procedure.\n3. Patient participation in an interventional clinical study that could impact primary outcomes results.\n4. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above.\n5. Patients undergoing a concomitant surgical procedure.\n6. Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg\u002Fm2).","ALL","22 Years",{"count":113,"type":114},30,"ESTIMATED","INTERVENTIONAL",[55],"The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery",[119],"Robotic Assisted Inguinal Hernia Repair",[121,122,123],"Versius","Robotic surgery","Inguinal hernia","NOT_YET_RECRUITING","2025-12-18",{"date":127,"type":128},"2026-01-05","ACTUAL",{"date":130,"type":114},"2026-03",{"date":132,"type":114},"2026-12",{"name":5,"class":6},1]