Evaluating the use of bioactive glass for filling the mastoid in cholesteatoma surgery
Official title: Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
Run by Centre Hospitalier Intercommunal Creteil · NCT05921643 · Data updated 2026-11-12
This study is testing if using a special type of glass to fill in the ear during cholesteatoma surgery helps patients heal better and prevents the problem from coming back.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 1 site (Lyon, Pierre-Bénite) |
| Status | Recruiting |
| Started | September 29, 2023 |
| Main results expected | March 2028 |
| Study ends | April 2030 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT05921643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with proven cholesteatoma requiring surgical intervention.
✕Probably not a fit
Patients with congenital cholesteatoma, previous surgeries for cholesteatoma, or those requiring an open surgical technique may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study involves adult patients with cholesteatoma who are undergoing surgery at the ENT department of Hospices Civils de Lyon. The closed surgical technique will be employed, where a filling material (GlassBONE™ or Bonalive™) is used to stabilize the cartilaginous fragment and prevent recurrence. Patients will be monitored post-operatively through a series of consultations at specified intervals to assess complications, healing, and quality of life. Imaging studies will also be conducted to evaluate the effectiveness of the filling material over time.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce recurrence rates in cholesteatoma patients.
How similar studies have gone: While the use of bioactive glass in mastoid filling is a relatively novel approach, similar studies have shown promising results in other surgical applications.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Lyon Sud
Lyon, Pierre-Bénite, France Recruiting
Study contacts
- Study coordinator: Maxime fieux
- Email: maxime.fieux@chu-lyon.fr
- Phone: 04.72.66.64.15
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.