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

Meccellis Biotech

Status: Active, not recruiting

Conditions: Abdominal Wall Defect; Abdominal Hernia; Abdominal Wall Injury

Treatments: Device: CELLIS (Porcine Acellular Dermal Matrix, PADM)

Study type: Observational

Funder types: Industry

Identifiers

NCT04580511

AWR_01_CIP

Details and patient eligibility

About

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.

Full description

The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.

Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.

Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.

CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.