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Boomerang cartilage graft aims to patch stubborn eardrum holes

NCT ID NCT07823894

Cure Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers test a surgical technique that uses a boomerang-shaped piece of the patient's own cartilage and tissue to repair hard-to-close eardrum perforations. The study includes 50 adults with anterior or subtotal perforations that have been dry for at least three months. Surgeons perform the repair through the ear canal with an endoscope, then check graft healing and hearing at 1, 3, and 6 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a boomerang-shaped cartilage and perichondrium graft taken from the patient's own tissue
What this could lead to
If it works, this technique could offer a more reliable way to close difficult eardrum perforations and improve hearing in people with chronic ear disease.
What could go wrong
This is a small, single-center study with no comparison group, so results may not apply broadly. The graft could fail to take, slip out of place, or leave hearing unchanged.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Anterior or subtotal tympanic membrane perforation * Dry ear for at least 3 months prior to surgery * Intact and mobile ossicular chain on clinical and intraoperative assessment * Aerated middle ear with healthy or near-normal middle ear mucosa * No evidence of cholesteatoma * Ability to attend all scheduled postoperative follow-up visits * Provision of written informed consent Exclusion Criteria: * Active ear discharge at the time of surgery * Presence of cholesteatoma * Marginal or attic perforation associated with pathology requiring mastoid surgery * Ossicular discontinuity or erosion requiring ossiculoplasty * Significant adhesive otitis media * Previous failed tympanoplasty in the same ear * Severe Eustachian tube dysfunction associated with adhesive disease * Craniofacial anomalies affecting the ear * Uncontrolled systemic disease contraindicating surgery * Narrow external auditory canal precluding endoscopic access * Inability to complete the planned follow-up period

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Conditions

The condition(s) this trial relates to.

chronic otitis media Tympanic Membrane Perforation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic otitis media Tympanic membrane perforation

How to take part

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  1. 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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