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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580511
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
Meccellis Biotech

Study Description
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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.


Condition or disease Intervention/treatment
Abdominal Wall Defect Abdominal Wall Injury Abdominal Hernia Device: CELLIS (Porcine Acellular Dermal Matrix, PADM)

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 112 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Intervention Details:
  • Device: CELLIS (Porcine Acellular Dermal Matrix, PADM)
    Biological membrane used in abdominal reconstruction

Outcome Measures
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Primary Outcome Measures :
  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). [ Time Frame: From the surgical procedure throughout the entire 24-month follow-up period ]
    Percentage


Secondary Outcome Measures :
  1. Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage

  2. Rate of recurrence/incisional hernia requiring reoperation [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage

  3. Rate of abdominal wall laxity [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage

  4. 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. [ Time Frame: During the surgical procedure ]
    Summarized and listed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580511


Contacts
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Contact: Claire CISTERNI, PhD +33 (0)6 68 13 76 26 claire.cisterni@meccellis.com
Contact: Guillaume HOFMANSKI +33 (0)7 61 31 11 33 guillaume.hofmanski@meccellis.com

Locations
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France
CHU Caen Normandie, Service de Chirurgie Digestive Recruiting
Caen, France
Contact: Gil LEBRETON, MD         
Principal Investigator: Gil LEBRETON, MD         
Groupe Hospitalier La Rochelle - Ré - Aunis Recruiting
La Rochelle, France
Contact: Hélène GIBELIN, MD         
Principal Investigator: Hélène GIBELIN, MD         
CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation Recruiting
Montpellier, France
Contact: Hassan BOUYABRINE, MD         
Principal Investigator: Hassan BOUYABRINE, MD         
CHU Nantes Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Claire BLANCHARD-LOUIS, MD         
Principal Investigator: Claire BLANCHARD-LOUIS, MD         
Sponsors and Collaborators
Meccellis Biotech
Investigators
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Principal Investigator: Hassan BOUYABRINE, MD CHU Montpellier, France
More Information
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Responsible Party: Meccellis Biotech
ClinicalTrials.gov Identifier: NCT04580511    
Other Study ID Numbers: AWR_01_CIP
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meccellis Biotech:
abdominal wall reconstruction
biological mesh
Additional relevant MeSH terms:
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Hernia, Abdominal
Internal Hernia
Hernia
Pathological Conditions, Anatomical