[{"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:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},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",[24],"Pelvic Organ Prolapse",[26,27,28,29],"Apical Pelvic Organ Prolapse","Transvaginal repair","Mesh augmented repair","Sacrouterine ligament fixation","RECRUITING","2024-11-19",{"date":33,"type":34},"2024-11-22","ACTUAL",{"date":36,"type":34},"2022-12-19",{"date":38,"type":20},"2030-07",{"name":40,"class":41},"Promedon","INDUSTRY",7,""]