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

Abdominal Wall Defect Clinical Trial

— PMCF_AWR  

Official title:

Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580511
• Other study ID #: AWR_01_CIP
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: November 2026

Study information

• Verified date: October 2023
• Source: Meccellis Biotech
• Contact: Claire CISTERNI, PhD
• Phone: +33 (0)6 68 13 76 26
• Email: claire.cisterni[@]meccellis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Hernia
• Abdominal Wall Defect
• Abdominal Wall Injury
• Hernia, Abdominal
• Internal Hernia

Intervention

Device:
• CELLIS (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in abdominal reconstruction

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Meccellis Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan	Percentage	Throughout the study until end of the 24-month follow-up period
Secondary	Rate of recurrence/incisional hernia requiring reoperation	Percentage	Throughout the study until end of the 24-month follow-up period
Secondary	Rate of abdominal wall laxity	Percentage	Throughout the study until end of the 24-month follow-up period
Secondary	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.	Summarized and listed	During the surgical procedure