Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Recruiting now · Not applicable
Conditions studied: Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
In brief
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.
Key facts
- Study ID
- NCT07066761
- Run by
- A.M.I. Agency for Medical Innovations GmbH
- People needed
- 85
- Starts
- 2025-11-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- BZK St. Johann in Tirol — Sankt Johann in Tirol, Tyrol, Austria (enrolling)
- Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe — Wiener Neustadt, Austria (enrolling)
- 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
Full record on ClinicalTrials.gov
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