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.

NCT Number	NCT07497321
Lead Sponsor	A.M.I. Agency for Medical Innovations GmbH
Conditions	Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery, Sacrocolpopexy, Pelvic Floor Prolapse, Pelvic Floor, Implant
Enrollment	100 participants
Start Date	2026-04-15
Primary Completion	2028-07-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-27