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

Last updated: November 21, 2024
Sponsor: Meccellis Biotech
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

CELLIS (Porcine Acellular Dermal Matrix, PADM)

Clinical Study ID

NCT04580511
AWR_01_CIP
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient aged ≥18 years,

  • Patient with an indication of abdominal wall reconstruction including, but notlimited to, ventral hernia repair and stoma closure,

  • Patient being informed of its participation to the study and of the follow-upvisits, and having no objection to the clinical data collection and medical fileaccess,

  • Patient being informed of the porcine origin of the device in advance of theprocedure.

Exclusion

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.

Study Design

Total Participants: 92
Treatment Group(s): 1
Primary Treatment: CELLIS (Porcine Acellular Dermal Matrix, PADM)
Phase:
Study Start date:
November 04, 2020
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • CHU Caen Normandie, Service de Chirurgie Digestive

    Caen,
    France

    Site Not Available

  • Groupe Hospitalier La Rochelle - Ré - Aunis

    La Rochelle,
    France

    Site Not Available

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

    Montpellier,
    France

    Site Not Available

  • CHU Nantes Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

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