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New light device aims to end guesswork in ear infection diagnosis

NCT ID NCT04812093

Diagnosis Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device that uses special lights to look at the eardrum and detect fluid behind it, which is a sign of middle ear infection. The goal is to make diagnosis more accurate than current methods. The study will include 150 people of all ages who are scheduled for ear tube surgery.

What this could mean

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

Active substance
Spectroscopic otoscope device
What this could lead to
If successful, this could lead to a more accurate, non-invasive way to diagnose middle ear infections, reducing misdiagnosis and unnecessary surgeries.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The device may not prove more accurate than current methods, and results may not apply to all patients.

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 150 people

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

Started

Feb 2021

Expected to finish

Dec 2028

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

UCI otolaryngology clinic, CHOC, and La Veta

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Male/ female at all age- newborn to adult. 2. Non- pregnant woman. 3. Diagnose of middle ear infection and plan for surgery procedure. Exclusion Criteria: 1. Pregnant woman 2. Incompetent adults (i.e. individuals with cognitive impairment) 3. No diagnose of middle ear infection and no plan for surgery procedure. 4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

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Conditions

The condition(s) this trial relates to.

infectious otitis media otitis media

As listed by the trial registrant

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

Middle ear infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Children's Hospital of Orange County (CHOC)

    RECRUITING

    Orange, California, 92868, United States

  • UCI Otolaryngology Clinic

    RECRUITING

    Orange, California, 92868, United States

More trials for these conditions

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