Cholesteatoma Clinical Trial
— GLASS-BONAOfficial title:
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
NCT number | NCT05921643 |
Other study ID # | GLASS-BONA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 29, 2023 |
Est. completion date | April 2026 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 2026 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients at least 18 years old - Patients with proven cholesteatoma - Patient requiring and agreeing to surgery with filling of the mastoid or tympanic epi (closed technique with filling) - Patient having a surgery with filling in first intention Exclusion Criteria: - Background: - Known outer, middle or inner ear malformation - Congenital cholesteatoma - Previously operated cholesteatoma - Cholesteatoma requiring an open technique or presenting with chronic non-cholesteatomatous otitis - Contraindications to the use of GlassBONE™ or Bonalive™ - Pregnant, parturient or nursing mothers - Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, adults subject to a measure of legal protection or unable to express themselves - Patient participating in interventional research excluding routine care research (old regulations) and category 2 research that does not interfere with the analysis of the primary endpoint - Patient objecting to the use of their data |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Lyon Sud | Lyon | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mastoid filling | A patient will be considered as a responder if the proportion of mastoid filling at 6 months is strictly greater than 70% compared to the reference measurement | 6 month |
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