Bioactive glass could ease ear surgery After-Effects
NCT ID NCT07496112
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using bioactive glass granules during a second ear surgery can improve quality of life for people with ongoing problems like discharge, dizziness, or trouble using hearing aids. Fifty adults who had prior ear surgery will receive the procedure and be followed for changes in symptoms and daily function. The goal is to see if this material makes the ear cavity more stable and reduces complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- S53P4 bioactive glass granules
- What this could lead to
- If successful, this could offer a safe way to improve daily life for people with chronic ear cavity problems after surgery.
- What could go wrong
- This is a small, early-stage study with only 50 participants. The procedure is surgical and carries risks like infection or failure to improve symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult patients requiring rehabilitation of radical open cavity after a previous canal wall down tympanoplasty. The trial will include at least 50 consecutives patients whom it is planned rehabilitation of radical cavity and mastoid obliteration with S53P4 Bonalive granules. Patients with a history of canal wall down (CWD) tympanoplasty who present with persistent symptoms such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * underwent a canal wall down tympanoplasty or a previous obliteration attempt more than a year ago * present with symptoms related to unstable cavity such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included * patients Over 18 years who signed informed consent Exclusion Criteria: * Active cholesteatoma * Earlier radiation of Head and Neck area * Pregnancy * Important systemic comorbidities
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Trial Office
Legnano, Italy, 20025, Italy
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