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RECRUITING
NCT07066761
NA

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

Sponsor: A.M.I. Agency for Medical Innovations GmbH

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2025-07-01

Completion Date

2027-07

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DEVICE

Laparoscopic lateral suspension with surgical mesh (LatGYNious)

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

Locations (5)

BZK St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, Austria

LKH Feldkirch, Gynäkologie und Geburtshilfe

Feldkirch, Austria

Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe

Brandenburg, Germany

Krankenhaus St. Joseph-Stift Bremen

Bremen, Germany

Medizincampus Bodensee - Klinik Tettnang

Tettnang, Germany