Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Recruiting
N/A
Interventional Study
Pelvic Organ Prolapse (POP)
Genital Prolapse
Uterus Prolapse
Laparoscopic Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 85 (estimated)
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH · Industry
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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.
Trial Locations
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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 proced…
Contacts