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Clinical Trials in France / NCT05921643
Recruiting Observational

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

NCT05921643 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Intercommunal Creteil
Phase
Observational
Started
2023-09-29
Last updated
2026-06-16

Condition(s) studied

Cholesteatoma

Investigational drug(s) / intervention(s)

verre bioactif 45S5 GlassBONEverre bioactif S53P4 Bonalive

verre bioactif 45S5 GlassBONE: All patients will benefit from surgical management for a first stage cholesteatoma 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. The mastoid filler used is left to the discretion and habits of the surgeon.

verre bioactif S53P4 Bonalive: All patients will benefit from surgical management for a first stage cholesteatoma 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. The mastoid filler used is left to the discretion and habits of the surgeon.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • mastoid filling — 6 month
    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

Trial sites (1)

FacilityCityRegionStatus
Hôpital Lyon Sud Lyon Pierre-Bénite Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05921643 on ClinicalTrials.gov ↗ ← All trials in France