Active — Not RecruitingNot Applicable

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

France92 participantsStarted 2020-11-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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).

Timeframe: From the surgical procedure throughout the entire 24-month follow-up period

Trial details

NCT IDNCT04580511

SponsorMeccellis Biotech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-11