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New ultrasound otoscope aims to spot ear infections with greater accuracy

NCT ID NCT06429709

Diagnosis Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests an advanced ultrasound otoscope, a device that uses sound waves to look inside the ear and detect fluid behind the eardrum. Researchers will compare its readings to the surgeon's findings during ear tube surgery in 300 children up to 12 years old. The goal is to improve diagnosis of middle ear infections, potentially leading to better treatment decisions.

What this could mean

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

Active substance
Advanced Ultrasound Otoscope (device)
What this could lead to
If successful, this device could help doctors more accurately diagnose ear infections, reducing unnecessary antibiotic use or missed infections.
What could go wrong
This is an early-stage study focused on algorithm development, not a treatment. The device may not prove more accurate than current methods, and results may not apply to all children.

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

About 300 people

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

Started

Sep 2021

Expected to finish

Dec 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.

Who is studied

The investigators will be recruiting patients between 0 months and 12 years of age who meet the listed inclusion criteria and do not meet any of the listed exclusion criteria. The investigators are not selecting patients based on race/ethnicity or gender/sex. Parents must be fluent in either English or Spanish.

Ages

0 to 12 years

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: * Newborn to 12 years of age * Receiving first set of pressure equalization (PE) tubes, even if coordinated with other procedures such as adenoidectomy * Indication for surgery includes recurrent acute otitis media, chronic otitis media with effusion, Eustachian tube dysfunction, and/or hearing loss. Exclusion Criteria: * Cholesteatoma, tympanic membrane perforation, myringitis * History of PE tube placement or PE tubes currently in place.

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Conditions

The condition(s) this trial relates to.

ear infection eustachian tube disorder hearing loss disorder infectious otitis media otitis media otitis media with effusion otitis media, susceptibility to

As listed by the trial registrant

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

Ear infection Middle ear infection Otitis media recurrent

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

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