Clinical Trial

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

Study acronym: GLASS-BONA
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-06-16; most recent amendment 2026-06-15.
Status change: Not Yet Recruiting → Recruiting 2024-03-27
Trial Details
NCT Number NCT05921643
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions Cholesteatoma
Enrollment 70 participants
Start Date 2023-09-29
Primary Completion 2028-03 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-16