BridgeMD
New treatment option for Prolapse; Female
Official title Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
ClinicalTrials.gov ID: NCT06404931
What this study is testing
- What it's testing
- This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join if
- Women with symptomatic POP with indication of vaginal surgery.
- Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
- Women ≥18 years old.
- Women wishing to complete a 36-month follow-up.
- Understand and accept the study procedures and sign the informed consent.
You likely can't join if
- Women with previous pelvic floor or prolapse surgery
- Women with POP grade IV
- Women with chronic pelvic pain.
- Not being able to understand the nature of the study and/or the procedures to be followed.
- Not signing the informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Terrassa, Spain
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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Terrassa, Spain. 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.