NCT06430931 Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
| NCT ID | NCT06430931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meander Medical Center |
| Condition | Colorectal Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2023-12-06 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Esther Consten, Prof.dr
PRINCIPAL INVESTIGATOR
Meander Medisch Centrum
Frequently Asked Questions
Who can join the NCT06430931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06430931 currently recruiting?
Yes, NCT06430931 is actively recruiting participants. Contact the research team at ma.boom@meandermc.nl for enrollment information.
Where is the NCT06430931 trial being conducted?
This trial is being conducted at Amersfoort, Netherlands.
Who is sponsoring the NCT06430931 clinical trial?
NCT06430931 is sponsored by Meander Medical Center. The principal investigator is Esther Consten, Prof.dr at Meander Medisch Centrum. The trial plans to enroll 184 participants.