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

Launched by A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called LatGYNious, which is a mesh implant designed to help women who have pelvic organ prolapse. This condition happens when the muscles and tissues supporting the pelvic organs, like the uterus or bladder, become weak or loose, causing these organs to drop or bulge into the vagina. The goal of the trial is to see if the LatGYNious implant is safe to use and if it can effectively improve this problem in women who need surgery for their prolapse.

Women between the ages of 65 and 74 who have noticeable pelvic organ prolapse of a certain level (grade 2 or higher) and are planning to have surgery may be eligible to join. To participate, women must be willing to attend follow-up visits after the surgery and agree to the study rules. However, women who have had previous mesh surgery for prolapse, are pregnant, have certain cancers, allergies to the implant material, or are involved in other studies would not be able to join. If accepted, participants will receive the LatGYNious implant during their surgery and will be monitored afterward to check how well the device works and to ensure it is safe. This study is currently recruiting participants.

Gender

FEMALE

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