RecruitingNot ApplicableNCT07066761
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)
Sponsor
A.M.I. Agency for Medical Innovations GmbH
Enrollment
85 participants
Start Date
Jul 1, 2025
Study Type
INTERVENTIONAL
Summary
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
DEVICELaparoscopic lateral suspension with surgical mesh (LatGYNious)
Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07066761