[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517943":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":78,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":107,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SYMMCORA®",null,"Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).",[13],"Device: Closure of the Vaginal Cuff after Total Hysterectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"V-Loc®","Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Closure of the Vaginal Cuff after Total Hysterectomy","Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).",[9,15],[25],"Suturing",[27],{"name":28,"affiliation":29,"role":30},"Amadeus Hornemann, Prof. Dr.","Klinikum Sachsenhausen der DGD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Petra Baumann","CONTACT","+49746195","1646","petra.baumann@aesculap.de",[39,55],{"facility":29,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Frankfurt am Main","Hesse","60594","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],8.68417,50.11552,{"lat":50,"lon":49},[53,54],{"name":28,"role":34,"phone":10,"phoneExt":10,"email":10},{"name":28,"role":30,"phone":10,"phoneExt":10,"email":10},{"facility":56,"status":40,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hospital Sant Joan de Déu de Manresa","Manresa","Barcelona","08243","Spain","ES",{"type":47,"coordinates":63},[64,65],1.82399,41.72815,{"lat":65,"lon":64},[68,70,71,74,76],{"name":69,"role":34,"phone":10,"phoneExt":10,"email":10},"Lourdes Hinojosa Sánchez, Dra.",{"name":69,"role":30,"phone":10,"phoneExt":10,"email":10},{"name":72,"role":73,"phone":10,"phoneExt":10,"email":10},"Arantxa Monteils Llabenia, Dra.","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":10,"phoneExt":10,"email":10},"Núria Grané Garcia, Dra",{"name":77,"role":73,"phone":10,"phoneExt":10,"email":10},"Carmen Bergos Sorolla, Dra.",{"type":79,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[81],{"name":82,"class":6},"B.Braun Surgical SA","100517943","performance-of-symmcora-vs-v-loc-suture-material-in-patients-undergoing-laparoscopic-total-hysterectomy-100517943",false,"NCT06024109","Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy","Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy","BARHYSTER","Inclusion Criteria:\n\n* Females undergoing an elective, laparoscopic total hysterectomy\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Open surgery\n* Patients undergone immunosuppressive drug treatment within the prior 6 months\n* Patients with hypersensitivity or allergy to the suture material.\n* Participation in another clinical study\n* Non-compliance of patient","FEMALE","18 Years",{"count":94,"type":95},132,"ESTIMATED","OBSERVATIONAL","The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.\n\nSecondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.",[99,100,101,102,103,104,105,106],"Abnormal Uterine Bleeding","Endometriosis","Uterine Prolapse","Uterine Cancer","Ovarian Cancer","Fallopian Tube Cancer","Cervical Cancer","Endometrial Cancer",[108,109,110,111],"Barbed Suture","Hysterectomy","Laparoscopy","Minimal Invasive","2026-06-01",{"date":114,"type":115},"2026-06-02","ACTUAL",{"date":117,"type":115},"2024-03-19",{"date":119,"type":95},"2027-08",{"name":5,"class":6},2]