NCT05921643 Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
| NCT ID | NCT05921643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Cholesteatoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-09-29 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05921643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cholesteatoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05921643 currently recruiting?
Yes, NCT05921643 is actively recruiting participants. Contact the research team at maxime.fieux@chu-lyon.fr for enrollment information.
Where is the NCT05921643 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05921643 clinical trial?
NCT05921643 is sponsored by Centre Hospitalier Intercommunal Creteil. The trial plans to enroll 70 participants.