CholesteatomaGLASS-BONANCT05921643
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
An observational study of Cholesteatoma, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholesteatoma
- What is being tested?
- verre bioactif 45S5 GlassBONE and verre bioactif S53P4 Bonalive
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2023to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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™
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud
Lyon, Pierre-Bénite, 69495
Maxime FIEUX, 04.72.66.64.15, maxime.fieux@chu-lyon.fr
About this study
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.
Read the detailed description
Patients are operated on as an outpatient and receive a phone call the next morning to look for an initial complication. The patients will be reviewed in consultation at D8, D45, 3 months, 6 months and at 18 months with clinical examination (otoscopy) and audiometry at each consultation. The consultation on D8 is used for removal of the expandable cotton put in place in the external auditory canal (CAE) during surgery to guide healing, control post-auricular healing and look for signs of complication during the examination. A cone beam (CBCT) is performed during the consultation on D45 to confirm the correct position of the ossiculoplasty and check the persistence of the initial filling. The proportion of filled mastoid at D45 will serve as a reference to then be compared to the CT scan at 6 months and at 18 months. During surgery, and at the consultation at 6 months and 18 months, patients will also have to complete a quality of life questionnaire (Chronic Ear Survey French version; in the Appendix).
- Conditions
- Cholesteatoma
- Being tested
- verre bioactif 45S5 GlassBONE, verre bioactif S53P4 Bonalive
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verre bioactif 45S5 GlassBONEDevice
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 BonaliveDevice
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 group | Role | What they receive |
|---|---|---|
| patient with cholesteatoma who has never been operated on | 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. Receives: Device: verre bioactif 45S5 GlassBONE; Device: verre bioactif S53P4 Bonalive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start29 Sep 2023
- Primary completionMar 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesteatomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921643
- Sponsor's protocol ID
- GLASS-BONA
- Acronym
- GLASS-BONA
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
- ClinicalTrials.gov ID
- NCT05921643
- Acronym / sponsor ID
- GLASS-BONA / GLASS-BONA
- Conditions
- Cholesteatoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients are operated on as an outpatient and receive a phone call the next morning to look for an initial complication. The patients will be reviewed in consultation at D8, D45, 3 months, 6 months and at 18 months with clinical examination (otoscopy) and audiometry at each consultation. The consultation on D8 is used for removal of the expandable cotton put in place in the external auditory canal (CAE) during surgery to guide healing, control post-auricular healing and look for signs of complication during the examination. A cone beam (CBCT) is performed during the consultation on D45 to confirm the correct position of the ossiculoplasty and check the persistence of the initial filling. The proportion of filled mastoid at D45 will serve as a reference to then be compared to the CT scan at 6 months and at 18 months. During surgery, and at the consultation at 6 months and 18 months, patients will also have to complete a quality of life questionnaire (Chronic Ear Survey French version; in the Appendix).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with cholesteatoma who has never been operated on | – | Device: verre bioactif 45S5 GlassBONE, Device: verre bioactif S53P4 BonaliveAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verre bioactif 45S5 GlassBONEAll 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. | Device | patient with cholesteatoma who has never been operated on |
| verre bioactif S53P4 BonaliveAll 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. | Device | patient with cholesteatoma who has never been operated on |
Primary outcome
mastoid filling
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Cholesteatoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholesteatoma, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime fieux (04.72.66.64.15, maxime.fieux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mastoid filling (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.