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Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

NCT04580511 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2024-11-22

No results posted yet for this study

Summary

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.

The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

Conditions

  • Abdominal Wall Defect
  • Abdominal Wall Injury
  • Abdominal Hernia

Interventions

DEVICE

CELLIS (Porcine Acellular Dermal Matrix, PADM)

Biological membrane used in abdominal reconstruction

Sponsors & Collaborators

  • Meccellis Biotech

    lead INDUSTRY

Principal Investigators

  • Hassan BOUYABRINE, MD · CHU Montpellier, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2026-11-30
Completion
2026-11-30

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 NCT04580511 on ClinicalTrials.gov