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Compares treatment options for Colorectal Disorders
Official title Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
ClinicalTrials.gov ID: NCT06430931
What this study is testing
- What it's testing
- This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
- 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 and older
You may be able to join if
- Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse;
- Counselled for therapeutic options and given informed consent for VMR or SCR;
- Counselled for different types of mesh (OviTex or Prolene) and randomisation;
- Written informed consent for randomisation, OviTex implant or Prolene;
- Written informed consent for observational data collection.
You likely can't join if
- Mentally incompetent patients (unable to fulfil questionnaires).
- Allergy to ovine rumen.
- A medical history of pelvic radiation therapy.
- Scheduled for a redo-rectopexy.
- A medical history of previously implanted pelvic floor meshes or native tissue.
- Language barrier
The study team makes the final eligibility decision.
Where it's taking place
- Amersfoort, Utrecht, Netherlands
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amersfoort, Utrecht, Netherlands. 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.