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Can 3D imaging sharpen the diagnosis and surgery of a common hearing condition?

NCT ID NCT05921578

Diagnosis Sponsor: Rigshospitalet, Denmark 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study investigates whether cone-beam computed tomography (CBCT), a 3D imaging technique, can improve the diagnosis and surgical treatment of otosclerosis, a condition where abnormal bone growth in the middle ear causes hearing loss. Researchers will enroll 100 adults suspected of having otosclerosis to measure how accurately CBCT detects the disease and how well it helps surgeons plan the placement of a prosthetic device during stapedotomy, a corrective surgery. The study also tracks hearing outcomes after surgery to see if CBCT-based planning leads to better results.

What this could mean

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

Active substance
Cone-beam computed tomography (CBCT) imaging of the temporal bone
What this could lead to
If CBCT proves accurate, it could become a standard tool for diagnosing otosclerosis and planning stapedotomy, potentially improving surgical precision and hearing outcomes.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. CBCT may not outperform current methods, and its impact on surgical success remains uncertain.

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 100 people

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

Started

May 2023

Expected to finish

Dec 2026

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: * Adults (\>18 years of age). * Referred to our department suspected for otosclerosis. * Consents to participation in the project. Exclusion Criteria: * A history of surgical treatment for otosclerosis (ipsilateral ear). * A history of tympanoplasty type 2-4 (ipsilateral ear). * Other competing middle-ear diseases (ipsilateral ear). Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to: Exclusion: \- Intraoperative findings not supporting otosclerosis.

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Conditions

The condition(s) this trial relates to.

otosclerosis progressive deafness with stapes fixation

As listed by the trial registrant

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

Cone-beam computed tomography Otosclerosis Stapes fixation

Contacts and locations

Locations

  • Rigshospitalet

    Copenhagen, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.