[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"A.M.I. Agency for Medical Innovations GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100631180","safety-and-performance-of-a-pelvic-floor-mesh-implant-for-laparoscopic-sacrocolpopexy-progynious-100631180",false,"NCT07497321","Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)","ProGYNious","Inclusion Criteria:\n\n* Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation\n* Symptomatic pelvic organ prolapse with POP-Q \\>= 2\n* Age \\>18 years and ≤ 80years\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\n\nExclusion Criteria:\n\n* previous or concurrent cancer which may affect the successful treament with laparoscopic mesh\n* known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene)\n* known severe osteoporosis\n* pregnancy, suspected pregnancy and breastfeeding\n* bleeding of unknown cause in the genital area\n* previously irradiated patients in the pelvic area\n* drug or medication abuse, medical, psychological or social circumstances that could affect the patient's participation in the study or the evaluation of the study results\n* Any previous interventions with surgical mesh for pelvic organ prolapse and\u002For urinary incontinence\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\n* patients with an increased risk of infection or impaired wound healing (e.g. Diabetes mellitus with HbA1c \\>10, systemic autoimmune diseases, etc.)\n* concomitant Sling\u002FTVT procedure\n* life expectancy lower than follow-up period (e.g. ASA 4)\n* non-symptomatic pelvic organ prolapse\n* chronic pain syndrome\n* chronic respiratory disease (e.g. COPD, chronic cough)","FEMALE","18 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.",[27,28,29,30,31,32,33,34],"Pelvic Organ Prolapse (POP)","Synthetic Mesh","Laparoscopic Surgery","Gynecologic Laparoscopic Surgery","Sacrocolpopexy","Pelvic Floor Prolapse","Pelvic Floor","Implant",[14,36,37,38,39,40],"A.M.I.","AMI","Agency for Medical Innovation","Y Mesh","Progyn","NOT_YET_RECRUITING","2026-03-24",{"date":44,"type":45},"2026-03-27","ACTUAL",{"date":47,"type":21},"2026-04-15",{"date":49,"type":21},"2028-09-30",{"name":51,"class":52},"A.M.I. Agency for Medical Innovations GmbH","INDUSTRY",5,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":53},"100598074","safety-and-performance-of-a-pelvic-floor-mesh-implant-latgynious-100598074","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",{"count":62,"type":21},85,[24],"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.",[27,66,67,29],"Genital Prolapse","Uterus Prolapse",[69],"Laparoscopic lateral suspension (LLS)","RECRUITING","2025-07-15",{"date":73,"type":45},"2025-07-18",{"date":75,"type":45},"2025-07-01",{"date":77,"type":21},"2027-07",{"name":51,"class":52},""]