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

A.M.I. Agency for Medical Innovations

Status: Not yet enrolling

Conditions: Laparoscopic Surgery; Pelvic Organ Prolapse (POP); Pelvic Floor; Synthetic Mesh; Sacrocolpopexy; Pelvic Floor Prolapse; Implant; Gynecologic Laparoscopic Surgery

Treatments: Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07497321

PMCF-51-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form

Exclusion criteria

• 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
• bleeding of unknown cause in the genital area
• previously irradiated patients in the pelvic area
• 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
• Any previous interventions with surgical mesh for pelvic organ prolapse and/or urinary incontinence
• Unable to understand study requirements or is unable to comply with follow-up schedule
• Contraindicated according to the instruction for use of the device
• patients with an increased risk of infection or impaired wound healing (e.g. Diabetes mellitus with HbA1c >10, systemic autoimmune diseases, etc.)
• concomitant Sling/TVT procedure
• life expectancy lower than follow-up period (e.g. ASA 4)
• non-symptomatic pelvic organ prolapse
• chronic pain syndrome
• chronic respiratory disease (e.g. COPD, chronic cough)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Laparoscopic surgery with a synthetic mesh implant (ProGYNious)

Experimental group

Description:

Implantation of ProGYNious

Treatment:

Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious)