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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorA.M.I. Agency for Medical Innovations GmbH

About this trial

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.

Eligibility criteria

Qualifiers

Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation

Symptomatic pelvic organ prolapse with POP-Q >= 2

Age >18 years and ≤ 80years

Subject is willing and able to cooperate with follow-up examinations

Disqualifiers

previous or concurrent cancer which may affect the successful treament with laparoscopic mesh

known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene)

known severe osteoporosis

pregnancy, suspected pregnancy and breastfeeding

Trial design

Treatments tested in this trial

  • Surgical mesh for pelvic organ prolapse repair (ProGYNious)

Treatment groups

100 Participants
are divided into 1 treatment group