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Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Sponsor: A.M.I. Agency for Medical Innovations GmbH
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
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