[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566666":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":58,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":24,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Full visibility vnotes group","EXPERIMENTAL","A suitable size of multi-channel vaginal sealing instrument was inserted from the vagina, pneumoperitoneum formed air pressure, and the vaginal dome was dilated and fully exposed. The dome was opened under laparoscopy, and an approach platform was established to complete the total hysterectomy.",[13],"Device: Vnotes surgery using fully visualised surgical instruments",{"label":15,"type":10,"description":16,"interventionNames":17},"Traditional vnotes group","The vaginal fornix and part of cervical ligaments were incised by vaginal operation, and an approach platform was established to complete hysterectomy.",[18],"Device: Vnotes surgery using traditional surgical instruments",[20,25],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Vnotes surgery using fully visualised surgical instruments",[9],null,{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":24},"Vnotes surgery using traditional surgical instruments",[15],[29],{"name":30,"affiliation":5,"role":31},"Jing Liang, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","8684206115","jacyliang@sina.com",{"name":38,"role":34,"phone":35,"phoneExt":24,"email":39},"Yuebo Li, MD","yueboli@126.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Beijing","Beijing Municipality","086010","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":24,"email":36},"Fang Zhao, MD","+86-010-84206115",{"type":31,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Jing Liang","Director of Obstetrics and Gynecology","100566666","safety-and-efficacy-of-using-a-novel-full-visual-access-platform-system-in-transvaginal-hysterectomy-100566666",false,"NCT06658145","Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy","The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform","Inclusion Criteria:\n\n1. Female patients ≤ 60years old\n2. Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids\n3. BMI ranges from 18.5 to 27.9kg\u002Fm2;\n4. Informed consent signed by the subject himself or his legal representative.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women;\n2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;\n3. Preoperative examination for malignant possibility\n4. Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;\n5. Patients known to have severe hepatic or renal dysfunction;\n6. Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;\n7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;\n8. patients with acute infection;\n9. Known to have participated in any other clinical trial or taken hormone therapy within 3 months;\n10. who cannot sign the informed consent;\n11. For those with known or suspected poor compliance who could not complete the trial.","FEMALE","60 Years",{"count":71,"type":72},94,"ESTIMATED","INTERVENTIONAL",[75],"NA","The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.",[78,79],"Uterine Myoma","Surgery, Laparoscopic","2025-02-10",{"date":82,"type":83},"2025-02-12","ACTUAL",{"date":85,"type":72},"2025-02",{"date":87,"type":72},"2027-06",{"name":5,"class":6},1]