NCT07066761

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: A.M.I. Agency for Medical Innovations GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.

Detailed description

LatGYNious is a preformed 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 arms, which achieves a strong lateral fixation. The overlap area of the two mesh types is designed to combine the properties of both structures. In case of a uterus preserving approach, the posterior part of the mesh body is removed. The aim of the present study is to generate clinical data to show the safety and performance of LatGYNious for the treatment of female pelvic organ prolapse.

Conditions

• Pelvic Organ Prolapse (POP)
• Genital Prolapse
• Uterus Prolapse
• Laparoscopic Surgery

Interventions

Type	Name	Description
DEVICE	Laparoscopic lateral suspension with surgical mesh (LatGYNious)	Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2025-07-15
• Last updated: 2025-07-18

Locations

5 sites across 2 countries: Austria, Germany