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

Study acronym: PMCF_AWR
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Nov 2026 to Oct 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 112 to confirmed 92
    • Site details revised at 4 of 4 sites
    v5
  3. Primary and study completion dates: Nov 2024 to Nov 2026
    • Study sites: 3 to 4
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 2024 to Nov 2024
    • Start date changed from estimate of Oct 2020 to Nov 4, 2020
    • Site details revised at 3 of 3 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04580511
Lead Sponsor Meccellis Biotech
Conditions
(from sponsor)		 Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
Related terms Hernia, Abdominal
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov