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Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
Sponsor: Meccellis Biotech
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.
Official title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
92
Start Date
2020-11-04
Completion Date
2026-11
Last Updated
2024-11-22
Healthy Volunteers
No
Interventions
CELLIS (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in abdominal reconstruction
Locations (4)
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