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Clinical Trials in France / NCT04580511
Active, not recruiting Observational

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

NCT04580511 · tracked via the Priya Life Science France tracker
Sponsor
Meccellis Biotech
Phase
Observational
Started
2020-11-04
Last updated
2026-10-08

Condition(s) studied

Abdominal Wall DefectAbdominal Wall InjuryAbdominal Hernia

Investigational drug(s) / intervention(s)

CELLIS (Porcine Acellular Dermal Matrix, PADM)

CELLIS (Porcine Acellular Dermal Matrix, PADM): Biological membrane used in abdominal reconstruction

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged ≥18 years, * Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, * Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access, * Patient being informed of the porcine origin of the device in advance of the procedure. Exclusion Criteria: * Patient with known hypersensitivity to porcine materials, * Patient who is pregnant, * Patient having refused to participate to the study, * Patient refusing to return for the follow-up visits.

Primary outcome measure(s)

  • Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI). — From the surgical procedure throughout the entire 24-month follow-up period
    Percentage

Trial sites (4)

FacilityCityRegionStatus
CHU Caen Normandie, Service de Chirurgie Digestive Caen France
Groupe Hospitalier La Rochelle - Ré - Aunis La Rochelle France
CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation Montpellier France
CHU Nantes Hôtel Dieu Nantes France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04580511 on ClinicalTrials.gov ↗ ← All trials in France