NCT07497321

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: A.M.I. Agency for Medical Innovations GmbH · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

ProGYNious is a Y-shaped synthetic mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh neck which achieves a strong fixation to the sacral promontory. This study is a prospective international multi-center post-market clinical investigation with five participating medical centers.

Conditions

• Pelvic Organ Prolapse (POP)
• Synthetic Mesh
• Laparoscopic Surgery
• Gynecologic Laparoscopic Surgery
• Sacrocolpopexy
• Pelvic Floor Prolapse
• Pelvic Floor
• Implant

Interventions

Type	Name	Description
DEVICE	Surgical mesh for pelvic organ prolapse repair (ProGYNious)	Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

Timeline

• Start date: 2026-04-15
• Primary completion: 2028-07-30
• Completion: 2028-09-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

5 sites across 2 countries: Austria, Germany