Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
LKH Feldkirch, Gynäkologie und Geburtshilfe
RECRUITING
Feldkirch
BZK St. Johann in Tirol
RECRUITING
Sankt Johann In Tirol
Germany
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
NOT_YET_RECRUITING
Brandenburg
Krankenhaus St. Joseph-Stift Bremen
NOT_YET_RECRUITING
Bremen
Medizincampus Bodensee - Klinik Tettnang
NOT_YET_RECRUITING
Tettnang
Contact Information
Primary
Florian Blab
florian.blab@ami.at
+43 5522 90505 4062
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 85
Treatments
Active_comparator: Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
Related Therapeutic Areas
Sponsors
Leads: A.M.I. Agency for Medical Innovations GmbH