[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Promedon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100442520","long-term-evaluation-of-the-efficacy-and-safety-of-splentis-for-the-treatment-of-primary-apical-pelvic-organ-prolapse-100442520",false,"NCT05042453","Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse","Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse","SAXO","Inclusion Criteria:\n\n* non-fertile women\n* primary symptomatic uterine descent POP-Q≥2\n* Scheduled apical POP repair with Splentis\n* Willing and able to participate at study visits and to sign informed consent\n\nExclusion Criteria:\n\n* Fertile women\n* Recurrent apical prolapse\n* Women with post hysterectomy vaginal vault prolapse\n* Patients with active or latent infection of the vagina, cervix or uterus\n* Patients with previous or current vaginal, cervical or uterine cancer\n* Previous, current or planned pelvic radiation therapy\n* Known allergy to polypropylene.","FEMALE","18 Years",{"count":20,"type":21},140,"ESTIMATED","OBSERVATIONAL","This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse",[25],"Pelvic Organ Prolapse",[27,28,29,30],"Apical Pelvic Organ Prolapse","Transvaginal repair","Mesh augmented repair","Sacrouterine ligament fixation","RECRUITING","2024-11-19",{"date":34,"type":35},"2024-11-22","ACTUAL",{"date":37,"type":35},"2022-12-19",{"date":39,"type":21},"2030-07",{"name":41,"class":42},"Promedon","INDUSTRY",7,""]