Actively Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Led by Meander Medical Center · Updated on 2026-01-02
184
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
Sponsors
M
Meander Medical Center
Lead Sponsor
H
Health Holland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for ventral mesh rectopexy or sacrocolporectopexy set by the treating surgeon or gynecologist according to current guidelines on rectal and pelvic prolapse
- Counseled for therapeutic options and given informed consent for ventral mesh rectopexy or sacrocolporectopexy
- Counseled about different mesh types (OviTex or Prolene) and randomization
- Provided written informed consent for randomization and for receiving either OviTex implant or Prolene mesh
- Provided written informed consent for observational data collection
You will not qualify if you...
- Mentally incompetent patients unable to complete questionnaires
- Allergy to ovine rumen
- History of pelvic radiation therapy
- Scheduled for redo-rectopexy
- History of previously implanted pelvic floor meshes or native tissue repair
- Language barrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands, 3813TZ
Actively Recruiting
Research Team
M
Marije Boom, drs.
CONTACT
E
Esther Consten, Prof.dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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