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Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

NCT06430931 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-01-02

No results posted yet for this study

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.

Conditions

  • Colorectal Disorders
  • Prolapse
  • Prolapse Rectal
  • Prolapse Genital
  • Prolapse Pelvic
  • Rectocele
  • Prolapse Uterus
  • Cystocele
  • Enterocele
  • Prolapse Bladder
  • Prolapse; Cervix

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).

Sponsors & Collaborators

  • Health Holland

    collaborator OTHER

  • Meander Medical Center

    lead OTHER

Principal Investigators

  • Esther Consten, Prof.dr · Meander Medisch Centrum

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430931 on ClinicalTrials.gov