[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolapse-uterovaginal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolapse-uterovaginal":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100503560","pragmatic-evaluation-of-performance-and-safety-of-the-anchorsure-transvaginal-device-for-surgical-treatment-of-apical-prolapse-in-women-100503560",false,"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":20,"type":21},120,"ESTIMATED","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.",[25,26,27],"Prolapse; Female","Prolapse Uterovaginal","Prolapse; Cervix",[29],"pelvic organ prolapse","RECRUITING","2025-11-14",{"date":33,"type":34},"2025-11-17","ACTUAL",{"date":36,"type":34},"2023-05-11",{"date":38,"type":21},"2028-06-01",{"name":40,"class":41},"Centre Hospitalier Universitaire de Nīmes","OTHER",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100547204","phase-2-transvaginal-human-acellular-dermal-matrix-for-prolapse-treatment-100547204","NCT06404931","Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment","Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial","Inclusion Criteria:\n\n* Women with symptomatic POP with indication of vaginal surgery.\n* Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.\n* Women ≥18 years old.\n* Women wishing to complete a 36-month follow-up.\n* Understand and accept the study procedures and sign the informed consent.\n\nExclusion Criteria:\n\n* Women with previous pelvic floor or prolapse surgery\n* Women with POP grade IV\n* Women with chronic pelvic pain.\n* Not being able to understand the nature of the study and\u002For the procedures to be followed.\n* Not signing the informed consent","18 Years","100 Years",{"count":53,"type":21},90,"INTERVENTIONAL",[56],"PHASE2","This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.\n\nThey will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .\n\nPatients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.",[25,59,26],"Prolapse Genital","2025-01-15",{"date":62,"type":34},"2025-01-17",{"date":64,"type":34},"2024-07-01",{"date":66,"type":21},"2026-01-01",{"name":68,"class":41},"Hospital Mutua de Terrassa",1]