NCT07066761 Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
| NCT ID | NCT07066761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | A.M.I. Agency for Medical Innovations GmbH |
| Condition | Pelvic Organ Prolapse (POP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Tina Cadenbach-Blome, Dr. med.
PRINCIPAL INVESTIGATOR
Medizincampus Bodensee - Klinik Tettnang
Frequently Asked Questions
Who can join the NCT07066761 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Organ Prolapse (POP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07066761 currently recruiting?
Yes, NCT07066761 is actively recruiting participants. Contact the research team at florian.blab@ami.at for enrollment information.
Where is the NCT07066761 trial being conducted?
This trial is being conducted at Sankt Johann in Tirol, Austria, Feldkirch, Austria, Brandenburg, Germany, Bremen, Germany and 1 additional location.
Who is sponsoring the NCT07066761 clinical trial?
NCT07066761 is sponsored by A.M.I. Agency for Medical Innovations GmbH. The principal investigator is Tina Cadenbach-Blome, Dr. med. at Medizincampus Bodensee - Klinik Tettnang. The trial plans to enroll 85 participants.