Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorA.M.I. Agency for Medical Innovations GmbH
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
Treatment groups
85 Participants
are divided into 1 treatment groupLocations
5Austria
BZK St. Johann in Tirol6380, Sankt Johann in TirolTyrol, Austria
LKH Feldkirch, Gynäkologie und Geburtshilfe6800, Feldkirch Austria
Germany
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe14770, Brandenburg Germany
Krankenhaus St. Joseph-Stift Bremen28209, Bremen Germany
Sponsors and collaborators
A.M.I. Agency for Medical Innovations GmbH
Lead sponsor
Source ClinicalTrials.gov