Actively Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Led by A.M.I. Agency for Medical Innovations GmbH · Updated on 2025-07-18
85
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
- Candidate for surgical treatment of pelvic organ prolapse
- Willing and able to cooperate with follow-up examinations
- Signed informed consent and authorized use of information for research purposes
You will not qualify if you...
- Previous surgical treatment with a mesh implant for pelvic organ prolapse (anterior or posterior compartment)
- Active immunotherapy that may negatively affect mesh treatment
- Active cancer of the vagina, cervix, or rectum
- Known or suspected hypersensitivity to polypropylene
- Pregnancy
- Participation in another study at the same time
- Unable to understand study requirements or comply with follow-up schedule
- Contraindicated according to the device's instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
BZK St. Johann in Tirol
Sankt Johann in Tirol, Tyrol, Austria, 6380
Actively Recruiting
2
LKH Feldkirch, Gynäkologie und Geburtshilfe
Feldkirch, Austria, 6800
Actively Recruiting
3
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
Brandenburg, Germany, 14770
Not Yet Recruiting
4
Krankenhaus St. Joseph-Stift Bremen
Bremen, Germany, 28209
Not Yet Recruiting
5
Medizincampus Bodensee - Klinik Tettnang
Tettnang, Germany, 88069
Not Yet Recruiting
Research Team
F
Florian Blab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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