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Tests treatment safety and results for Pelvic Organ Prolapse (POP)
Official title Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
ClinicalTrials.gov ID: NCT07066761
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sankt Johann in Tirol, Tyrol, Austria
- Feldkirch, Austria
- Brandenburg, Germany
- Bremen, Germany
- Tettnang, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sankt Johann in Tirol, Tyrol, Austria; Feldkirch, Austria; Brandenburg, Germany; Bremen, Germany; Tettnang, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.