LatGYNious pelvic mesh for treating pelvic organ prolapse
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)
This study will try the LatGYNious preformed mesh during laparoscopic lateral suspension surgery to see if it improves prolapse symptoms in women who need surgical repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | A.M.I. Agency for Medical Innovations GmbH Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Sankt Johann in Tirol, Tyrol and 4 other locations) |
| Trial ID | NCT07066761 on ClinicalTrials.gov |
What this trial studies
The device is a preformed pelvic mesh that combines an ultra-light, elastic polypropylene body with reinforced mesh arms designed for strong lateral fixation. Patients with symptomatic pelvic organ prolapse grade 2 or higher who are candidates for surgical repair will receive laparoscopic lateral suspension using the LatGYNious implant, with the mesh posterior portion removed if uterus preservation is planned. The study will collect clinical data on safety outcomes and anatomical and functional performance over scheduled follow-up visits. The goal is to characterize complication rates, fixation strength, and prolapse recurrence after implantation.
Who should consider this trial
Good fit: Ideal candidates are women with symptomatic pelvic organ prolapse (grade 2 or higher) who are eligible for laparoscopic surgical repair and can attend follow-up visits.
Not a fit: Patients who previously had a mesh implant for prolapse, have known polypropylene allergy, active relevant cancer, pregnancy, or contraindications to the device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the LatGYNious mesh could provide firmer, longer-lasting support and lower recurrence of prolapse after surgery.
How similar studies have performed: Similar mesh-based repairs and laparoscopic lateral suspension procedures have shown improved anatomical outcomes in some series, but results are mixed because mesh-related complications have also been reported.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sankt Johann in Tirol, Tyrol and 4 other locations
- BZK St. Johann in Tirol — Sankt Johann in Tirol, Tyrol, Austria (Recruiting)
- LKH Feldkirch, Gynäkologie und Geburtshilfe — Feldkirch, Austria (Recruiting)
- Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe — Brandenburg, Germany (Not_yet_recruiting)
- Krankenhaus St. Joseph-Stift Bremen — Bremen, Germany (Not_yet_recruiting)
- Medizincampus Bodensee - Klinik Tettnang — Tettnang, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Tina Cadenbach-Blome, Dr. med. — Medizincampus Bodensee - Klinik Tettnang
- Study coordinator: Florian Blab
- Email: florian.blab@ami.at
- Phone: +43 5522 90505 4062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.