[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synthetic-mesh\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synthetic-mesh":28},{"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":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100436800","breast-mesh-used-in-two-staged-breast-reconstruction-100436800","NCT04967976","Breast Mesh Used in Two-staged Breast Reconstruction","A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.","Inclusion Criteria:\n\n1. Diagnosed with breast cancer\n2. More than 18 years old\n3. Karnofsky Performance Status (KPS) larger than 80\n4. No clinical or imaging evidence of distant metastasis\n5. BMI \\\u003C 35kg\u002Fm2\n6. Patients with no or mild breast ptosis\n7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.\n8. Mental Health Patient\n\n   \\-\n\n   Exclusion Criteria:\n\n1\\. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast\u002Fchest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug\u002Falcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion\n\n\\-","70 Years",{"count":63,"type":21},300,[24],"This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.",[67,68,69,28],"Breast Cancer","Radiation","Breast Reconstruction",[71,72,73,74],"breast cancer","breast reconstruction","radiation","synthetic mesh","RECRUITING","2021-07-19",{"date":78,"type":45},"2021-07-20",{"date":80,"type":21},"2021-08-01",{"date":82,"type":21},"2026-08-01",{"name":84,"class":85},"Tianjin Medical University Cancer Institute and Hospital","OTHER",6]