[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolapse-cervix\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolapse-cervix":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100549201","biological-ovitex-versus-synthetic-graft-in-robotic-prolapse-surgery-100549201",false,"NCT06430931","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial","ProTex","Inclusion Criteria:\n\n* Indication for VMR or SCR set by the treating surgeon\u002Fgynecologist in accordance to the current guidelines on rectal and pelvic prolapse;\n* Counselled for therapeutic options and given informed consent for VMR or SCR;\n* Counselled for different types of mesh (OviTex or Prolene) and randomisation;\n* Written informed consent for randomisation, OviTex implant or Prolene;\n* Written informed consent for observational data collection.\n\nExclusion Criteria:\n\n* Mentally incompetent patients (unable to fulfil questionnaires).\n* Allergy to ovine rumen.\n* A medical history of pelvic radiation therapy.\n* Scheduled for a redo-rectopexy.\n* A medical history of previously implanted pelvic floor meshes or native tissue.\n* Language barrier","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.",[27,28,29,30,31,32,33,34,35,36,37],"Colorectal Disorders","Prolapse","Prolapse Rectal","Prolapse Genital","Prolapse Pelvic","Rectocele","Prolapse Uterus","Cystocele","Enterocele","Prolapse Bladder","Prolapse; Cervix",[28,39,40,41,42,43],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","RECRUITING","2025-12-31",{"date":47,"type":48},"2026-01-02","ACTUAL",{"date":50,"type":48},"2023-12-06",{"date":52,"type":21},"2027-07-01",{"name":54,"class":55},"Meander Medical Center","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100503560","pragmatic-evaluation-of-performance-and-safety-of-the-anchorsure-transvaginal-device-for-surgical-treatment-of-apical-prolapse-in-women-100503560","NCT05836844","Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women","APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.","APAS","Inclusion Criteria:\n\n* Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and\u002For Bp ≥ -1 cm for the posterior compartment, and\u002For C ≥ -1 cm for the apical compartment including recurrence.\n* Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence.\n* All women who have not indicated any objection to participating in the study.\n* All women who have been correctly informed.\n\nExclusion Criteria:\n\n* Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry).\n* Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®.\n* Patients with uncontrolled diabetes mellitus.\n* Patients with active non-controlled or chronic gynaecologic or urinary tract infection and\u002For local tissue necrosis.\n* Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …).\n* Patients with a history of radiotherapy in the pelvic area.\n* Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month.\n* patients under ongoing oral anticoagulant therapy.\n* Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery\n* Patients with a preoperative infection contraindicating the surgery","FEMALE","50 Years",{"count":68,"type":21},120,"OBSERVATIONAL","Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.",[72,73,37],"Prolapse; Female","Prolapse Uterovaginal",[75],"pelvic organ prolapse","2025-11-14",{"date":78,"type":48},"2025-11-17",{"date":80,"type":48},"2023-05-11",{"date":82,"type":21},"2028-06-01",{"name":84,"class":55},"Centre Hospitalier Universitaire de Nīmes",4]