[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487632":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":43,"locations":49,"responsibleParty":67,"collaborators":34,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":34,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":34,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":52,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"CHA University","OTHER",[8,14,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Study 1 Vi-Sealer","EXPERIMENTAL","This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.",[13],"Device: Vi-Sealer",{"label":15,"type":16,"description":17,"interventionNames":18},"Study 1 Ligasure","ACTIVE_COMPARATOR","This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.",[19],"Device: Ligasure",{"label":21,"type":10,"description":11,"interventionNames":22},"Study 2 Vi-sealer",[13],{"label":24,"type":16,"description":25,"interventionNames":26},"Study 2 Other AHD","This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.",[27],"Device: Other AHD",[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Vi-Sealer","using Reusable device, Vi-Sealer",[9,21],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Ligasure","using Ligasure",[15],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Other AHD","Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure",[24],[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Hyun Park","CONTACT","+82-031-780-5640","p06162006@cha.ac.kr",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":34,"country":55,"countryCode":34,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"CHA Bundang Medical Center","RECRUITING","Seongnam-si","Gyeonggi-do","South Korea",{"type":57,"coordinates":58},"Point",[59,60],127.13778,37.43861,{"lat":60,"lon":59},[63,66],{"name":64,"role":46,"phone":47,"phoneExt":34,"email":65},"Min Jung Kim","tooncrunch@naver.com",{"name":45,"role":46,"phone":34,"phoneExt":34,"email":34},{"type":68,"investigatorFullName":45,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Professor","100487632","efficacy-and-safety-evaluation-of-vi-sealer-100487632",false,"NCT05629611","Efficacy and Safety Evaluation of Vi-sealer","Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)","Inclusion Criteria:\n\n1. Aged 20 to 65 years\n2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)\n3. Eligible for hysterectomy\n4. Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure\n\nExclusion Criteria:\n\n1. Large uterus size over 16 weeks of gestational age\n2. Cervical or intraligamentary fibroids\n3. Severe endometriosis (stage 3 or 4)\n4. Suspected malignancy of the uterus or adnexa\n5. Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)\n6. Previous pelvic surgery ≥ 3 times\n7. Not suitable for laparoscopic surgery","FEMALE","20 Years","65 Years",{"count":81,"type":82},280,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.",[88],"Benign Gynecologic Neoplasm",[90,91,36,92,93],"Advanced hemostatic devices","Advanced energy devices","Laparoscopic total hysterectomy","Vi-sealer","2024-09-30",{"date":96,"type":97},"2024-10-01","ACTUAL",{"date":99,"type":97},"2023-01-20",{"date":101,"type":82},"2025-10-31",{"name":45,"class":6},1]