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

A.M.I. Agency for Medical Innovations

Status: Enrolling

Conditions: Laparoscopic Surgery; Pelvic Organ Prolapse (POP); Genital Prolapse; Uterus Prolapse

Treatments: Device: Laparoscopic lateral suspension with surgical mesh (LatGYNious)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07066761

CI-52_001_LatGYNious

EUDAMED No: CIV-24-09-049116 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
• Subject is candidate for a surgical treatment of pelvic organ prolapse
• 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 and provided authorization to use and disclose information for research purposes.

Exclusion criteria

• Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)
• Active immunotherapy which may negatively affect the treatment with a surgical mesh
• Active cancer of the vagina / cervix / rectum
• . known or suspected hypersensitivity to Polypropylene
• Pregnancy
• participation in another study at the same time
• Unable to understand study requirements or is unable to comply with follow-up schedule
• Contraindicated according to the instruction for use of the device

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Active Comparator group

Treatment:

Device: Laparoscopic lateral suspension with surgical mesh (LatGYNious)