[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442520":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":38,"responsibleParty":120,"collaborators":10,"id":122,"slug":10,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":10,"enrollmentInfo":131,"targetDuration":10,"studyType":134,"phases":10,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Promedon","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hysteropexy using Splentis via vaginal route",null,"Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis",[13],"Device: Splentis® POP Tissue Anchoring System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Splentis® POP Tissue Anchoring System","Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Gert Naumann, MD","Helios Clinic Erfurt, Germany","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Christian Fünfgeld, MD","Clinic Tettnang",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Philipp Schelhorn","CONTACT","00498031900400","trials.de@promedon.com",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Lorena López, Ph.D, Bioeng","005493514596072","lorena.lopez@promedon.com",[39,53,64,75,86,97,109],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"DRK Hospital Chemnitz-Rabenstein","RECRUITING","Chemnitz","Germany",{"type":45,"coordinates":46},"Point",[47,48],12.92922,50.8357,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":10,"phoneExt":10,"email":10},"Torsten Brosche, Dr. med.",{"facility":54,"status":41,"city":55,"state":10,"zip":10,"country":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Helios Hospital Erfurt, Department of gynaecology","Erfurt",{"type":45,"coordinates":57},[58,59],11.03536,50.97734,{"lat":59,"lon":58},[62],{"name":63,"role":31,"phone":10,"phoneExt":10,"email":10},"Gert Naumann, PD Dr.habil.",{"facility":65,"status":41,"city":66,"state":10,"zip":10,"country":43,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"University Hospital Freiburg","Freiburg im Breisgau",{"type":45,"coordinates":68},[69,70],7.85222,47.9959,{"lat":70,"lon":69},[73],{"name":74,"role":31,"phone":10,"phoneExt":10,"email":10},"Markus Hübner, Prof. Dr. med.",{"facility":76,"status":41,"city":77,"state":10,"zip":10,"country":43,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Clinic Kassel","Kassel",{"type":45,"coordinates":79},[80,81],9.5,51.31667,{"lat":81,"lon":80},[84],{"name":85,"role":31,"phone":10,"phoneExt":10,"email":10},"Christiane Schiffner, Dr. med.",{"facility":87,"status":41,"city":88,"state":10,"zip":10,"country":43,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"St. Elisabeth Hospital","Leipzig",{"type":45,"coordinates":90},[91,92],12.37129,51.33962,{"lat":92,"lon":91},[95],{"name":96,"role":31,"phone":10,"phoneExt":10,"email":10},"Birgit Henne, Dr. med.",{"facility":98,"status":99,"city":100,"state":10,"zip":10,"country":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Hospital","NOT_YET_RECRUITING","Mannheim",{"type":45,"coordinates":102},[103,104],8.46694,49.4891,{"lat":104,"lon":103},[107],{"name":108,"role":31,"phone":10,"phoneExt":10,"email":10},"Benjamin Tuschy, Prof. Dr. med.",{"facility":110,"status":41,"city":111,"state":10,"zip":10,"country":43,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Hospital Tettnang","Tettnang",{"type":45,"coordinates":113},[114,115],9.59132,47.66857,{"lat":115,"lon":114},[118],{"name":119,"role":31,"phone":10,"phoneExt":10,"email":10},"Christian Fünfgeld, Dr.med.",{"type":121,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":132,"type":133},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",[137],"Pelvic Organ Prolapse",[139,140,141,142],"Apical Pelvic Organ Prolapse","Transvaginal repair","Mesh augmented repair","Sacrouterine ligament fixation","2024-11-19",{"date":145,"type":146},"2024-11-22","ACTUAL",{"date":148,"type":146},"2022-12-19",{"date":150,"type":133},"2030-07",{"name":5,"class":6},7]