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RECRUITING
NCT06430931
NA

Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

Sponsor: Meander Medical Center

View on ClinicalTrials.gov

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.

Official title: Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2023-12-06

Completion Date

2027-07-01

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

PROCEDURE

Minimal invasive abdominal prolapse surgery using Polypropylene mesh

All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).

PROCEDURE

Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh

All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).

Locations (1)

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands