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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

Tracking Information
First Submitted Date October 2, 2020
First Posted Date October 8, 2020
Last Update Posted Date October 23, 2023
Actual Study Start Date November 4, 2020
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2020)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 2, 2020)
  • 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
  • Rate of recurrence/incisional hernia requiring reoperation [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage
  • Rate of abdominal wall laxity [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
Official Title Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Abdominal Wall Defect
  • Abdominal Wall Injury
  • Abdominal Hernia
Intervention Device: CELLIS (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in abdominal reconstruction
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 2, 2020)		 112
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2026
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04580511
Other Study ID Numbers AWR_01_CIP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Meccellis Biotech
Original Responsible Party Same as current
Current Study Sponsor Meccellis Biotech
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Hassan BOUYABRINE, MD CHU Montpellier, France
PRS Account Meccellis Biotech
Verification Date October 2023