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Agency for Medical Innovations GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)","ACTIVE_COMPARATOR",null,[13],"Device: Laparoscopic lateral suspension with surgical mesh (LatGYNious)",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":19},"DEVICE","Laparoscopic lateral suspension with surgical mesh (LatGYNious)",[9],[20,21],"surgical POP treatment","Pelvic organ prolapse",[23],{"name":24,"affiliation":25,"role":26},"Tina Cadenbach-Blome, Dr. med.","Medizincampus Bodensee - Klinik Tettnang","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Florian Blab","CONTACT","+43 5522 90505 4062","florian.blab@ami.at",[34,52,66,82,96],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"BZK St. Johann in Tirol","RECRUITING","Sankt Johann in Tirol","Tyrol","6380","Austria",{"type":42,"coordinates":43},"Point",[44,45],12.4232,47.5233,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":11,"email":51},"Christian Deetjen, Prim.Dr.","+43 5352 606-500","deetjen@khsj.at",{"facility":53,"status":36,"city":54,"state":11,"zip":55,"country":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"LKH Feldkirch, Gynäkologie und Geburtshilfe","Feldkirch","6800",{"type":42,"coordinates":57},[58,59],9.59734,47.23645,{"lat":59,"lon":58},[62],{"name":63,"role":30,"phone":64,"phoneExt":11,"email":65},"Burghard Prim. Dr. Abendstein","+43 5522 303--2201","Burghard.Abendstein@lkhf.at",{"facility":67,"status":68,"city":69,"state":11,"zip":70,"country":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe","NOT_YET_RECRUITING","Brandenburg","14770","Germany",{"type":42,"coordinates":73},[74,75],6.14466,50.69716,{"lat":75,"lon":74},[78],{"name":79,"role":30,"phone":80,"phoneExt":11,"email":81},"Cormelia Dr. Müller","+49 3381411400","c.mueller@klinikum-brandenburg.de",{"facility":83,"status":68,"city":84,"state":11,"zip":85,"country":71,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Krankenhaus St. Joseph-Stift Bremen","Bremen","28209",{"type":42,"coordinates":87},[88,89],8.80717,53.07582,{"lat":89,"lon":88},[92],{"name":93,"role":30,"phone":94,"phoneExt":11,"email":95},"Kerstin Dr. Volkmer","+49 421\u002F 347- 1300","KVolkmerDr@sjs-bremen.de",{"facility":25,"status":68,"city":97,"state":11,"zip":98,"country":71,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Tettnang","88069",{"type":42,"coordinates":100},[101,102],9.59132,47.66857,{"lat":102,"lon":101},[105],{"name":106,"role":30,"phone":107,"phoneExt":11,"email":108},"Tina Dr. Cadenbach-Blome","+49 7542 531-6300","cadenbach-blome.tina@medizincampus.de",{"type":110,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100598074",false,"NCT07066761","Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)","Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)","Inclusion Criteria:\n\n* Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus\n* Subject is candidate for a surgical treatment of pelvic organ prolapse\n* Subject is willing and able to cooperate with follow-up examinations\n* Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.\n\nExclusion Criteria:\n\n* Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)\n* Active immunotherapy which may negatively affect the treatment with a surgical mesh\n* Active cancer of the vagina \u002F cervix \u002F rectum\n* . known or suspected hypersensitivity to Polypropylene\n* Pregnancy\n* participation in another study at the same time\n* Unable to understand study requirements or is unable to comply with follow-up schedule\n* Contraindicated according to the instruction for use of the device","FEMALE","18 Years",{"count":120,"type":121},85,"ESTIMATED","INTERVENTIONAL",[124],"NA","The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.",[127,128,129,130],"Pelvic Organ Prolapse (POP)","Genital Prolapse","Uterus Prolapse","Laparoscopic Surgery",[132],"Laparoscopic lateral suspension (LLS)","2025-07-15",{"date":135,"type":136},"2025-07-18","ACTUAL",{"date":138,"type":136},"2025-07-01",{"date":140,"type":121},"2027-07",{"name":5,"class":6},5]