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Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"

Study acronym: GLASS-BONA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 2026 to Mar 2028
    • Study completion date: Apr 2027 to Apr 2030
    v7
  2. Primary completion date: Mar 2025 to Mar 2026
    • Study completion date: Apr 2026 to Apr 2027
    v6
  3. Primary completion date: Mar 2024 to Mar 2025
    • Study completion date: Apr 2025 to Apr 2026
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: May 2024 to Mar 2024
    • Study completion date: May 2026 to Apr 2025
    • Start date changed from estimate of Nov 2023 to Sep 29, 2023
    • Site details revised
  5. Start date: Sep 2023 to Nov 2023
    • Primary completion date: Mar 2024 to May 2024
    • Study completion date: Mar 2026 to May 2026
    v3
  6. Start date: Jul 2023 to Sep 2023
    • Primary completion date: Jan 2024 to Mar 2024
    • Study completion date: Jan 2026 to Mar 2026
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on. All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.
Trial Details
NCT Number NCT05921643
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)		 Cholesteatoma
Related terms Cholesteatoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov