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

NCT04580511 | Active Not Recruiting

• 1 other identifier: AWR_01_CIP
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

abdominal wall reconstruction; biological mesh

Outcome Measures

Primary Outcomes (1)

• 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).

  Percentage

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

Secondary Outcomes (4)

• Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan

  Throughout the study until end of the 24-month follow-up period

• Rate of recurrence/incisional hernia requiring reoperation

  Throughout the study until end of the 24-month follow-up period

• Rate of abdominal wall laxity

  Throughout the study until end of the 24-month follow-up period

• Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.

  During the surgical procedure

Interventions

CELLIS (Porcine Acellular Dermal Matrix, PADM) DEVICE

Biological membrane used in abdominal reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meccellis Biotech: lead

Study Sites (4)

CHU Caen Normandie, Service de Chirurgie Digestive

Caen, France

Location

Groupe Hospitalier La Rochelle - Ré - Aunis

La Rochelle, France

Location

CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation

Montpellier, France

Location

CHU Nantes Hôtel Dieu

Nantes, 44093, France

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hassan BOUYABRINE, MD

  CHU Montpellier, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 8, 2020
• Study Start: November 4, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)