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Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

NCT06296316 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2026-01-28

No results posted yet for this study

Summary

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

Conditions

  • Genital Prolapse

Interventions

DEVICE

Restorelle Polypropylene Mesh

The Coloplast Restorelle® Polypropylene Mesh is a Class III, implantable, permanent, non-absorbable, single use device indicated to restore female pelvic floor anatomy by providing anatomical support and suspension as a bridging material to support deficient fascia that resulted in descent of the female pelvic organs (pelvic organ prolapse). Restorelle mesh is a synthetic, macroporous mesh constructed of medical grade knitted, monofilament polypropylene.

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Philippe Ferry, Dr · CH La Rochelle, France

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2024-11-06
Completion
2024-11-06

Countries

  • France

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 NCT06296316 on ClinicalTrials.gov