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Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)

RecruitingNA

Sponsor: A.M.I. Agency for Medical Innovations GmbH

Conditions: Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery

Interventions: Laparoscopic lateral suspension with surgical mesh (LatGYNious)

Countries: Austria, Germany

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Locations (5)

Sankt Johann in Tirol, Tyrol, Austria
Wiener Neustadt, Austria
Brandenburg, Germany
Bremen, Germany
Tettnang, Germany