ClinicalTrials.gov record NCT05921643

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study following adults having first-time cholesteatoma surgery using a closed technique with mastoid filling (surgeon's choice of GlassBONE™ or Bonalive™). Participants are followed with clinical exams, hearing tests, imaging, and quality-of-life questionnaires up to 18 months. The study uses the 45-day imaging as a reference to compare mastoid filling at later visits, with a main measure at 6 months.

What it is studying. The study tests how well bioactive glass (GlassBONE™ or Bonalive™) fills and remains in the mastoid after closed-technique cholesteatoma surgery over the short and medium term. It compares the amount of mastoid filling seen on imaging at 45 days (reference) with scans at 6 months and 18 months, and collects clinical exam findings, audiometry, and a chronic ear quality-of-life questionnaire. The registry defines a responder as having more than 70% mastoid filling at 6 months compared to the 45-day reference.

What the researchers hope to learn. To describe short- and medium-term persistence and degree of mastoid filling when bioactive glass materials are used in closed-technique cholesteatoma surgery. To relate imaging findings to clinical ear exam results, hearing tests, and patient-reported chronic ear quality-of-life over 18 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have the planned closed surgical treatment for cholesteatoma under general anesthesia, with the mastoid filled using GlassBONE™ or Bonalive™ (surgeon's choice). The morning after surgery there is a phone call to check for problems. Clinic visits are at day 8 (removal of ear packing and wound check), day 45, 3 months, 6 months and 18 months for ear exam and hearing tests. Imaging (cone‑beam CT at day 45; CT at 6 and 18 months) will check mastoid filling, and participants complete the Chronic Ear Survey (French) at surgery and at 6 and 18 months.

How the study is structured. A prospective observational cohort study: adults undergoing first-time closed-technique cholesteatoma surgery with mastoid filling are followed without adding experimental treatment. There is a phone check the morning after surgery and in-person visits at day 8, day 45, 3 months, 6 months and 18 months. Imaging (cone beam CT at day 45; CT comparisons at 6 and 18 months), otoscopic exams, audiometry at each visit, and quality-of-life questionnaires at surgery and at 6 and 18 months are part of the follow-up.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on cholesteatoma

Clinical trials1 trial listed for cholesteatomaEvery trial the registry lists for cholesteatoma, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in cholesteatoma researchLatest monthly update: September 2026. Includes: Hearing retesting. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 29, 2023
Primary completion
March 2028 (estimated)
Study completion
April 2030 (estimated)
Target enrollment
70 participants (estimated)
Last updated on registry
Jun 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Centre Hospitalier Intercommunal Creteil

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
interventional
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
CT scan
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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