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

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Intercommunal Creteil
NCT05921643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • verre bioactif 45S5 GlassBONE
  • verre bioactif S53P4 Bonalive
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Where

1 site
Hôpital Lyon Sud
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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