Status: Not yet recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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.
Participants needed: 100
Trial details
Age: 18-80Biological sex: FemaleType: InterventionalSponsor: A.M.I. Agency for Medical Innovations GmbHUpdated: Mar 27, 2026Locations: 5
Eligibility criteria
Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNiou... [+4]
previous or concurrent cancer which may affect the successful treament with lapa... [+15]