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Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Oct 2026 to Sep 22, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 1 of 10 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v5
  3. Site details revised at 2 of 10 sitesv4
  4. Primary and study completion dates: Sep 2025 to Oct 2026
    • Study sites: 7 to 10
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Oct 4, 2021
    • Site details revised at 7 of 7 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data related to other treatment modalities. The present study will be a prospective, multicentric, non-randomized and non-controlled trial involving 112 patients followed for 24 months. The study will be conducted in France in 7 investigational centres.
Trial Details
NCT Number NCT05031962
Lead Sponsor Meccellis Biotech
Conditions
(from sponsor)		 Breast Reconstruction Following Mastectomy
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov