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Infrared eye on ear infections: new device aims to see fluid that white light misses

NCT ID NCT06944795

Diagnosis Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether a short wave infrared (SWIR) otoscope can more accurately diagnose middle ear fluid in children than a standard white light otoscope. About 100 children scheduled for ear tube surgery will have images taken with both devices. The presence or absence of fluid will be confirmed during the procedure, allowing a direct comparison of diagnostic accuracy.

What this could mean

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

Active substance
Short Wave Infrared (SWIR) otoscope device
What this could lead to
If successful, this could lead to a more accurate, objective tool for diagnosing middle ear infections in children, reducing unnecessary treatments.
What could go wrong
This is a small, early-stage study. The device may not prove more accurate than current methods, and imaging quality could vary in real-world use.

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

Apr 2026

Expected to finish

Jul 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

1 year to 17 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: * Ages 1-17 * Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital * Undergoing tympanostomy tube placement as part of standard of care * Parents and/or patient has the ability to understand and the willingness to sign a written informed consent form or assent form. Exclusion Criteria: * Patients under 1 year of age or 18 and older * Participants not meeting the inclusion criteria

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Conditions

The condition(s) this trial relates to.

chronic otitis media ear infection otitis media otitis media with effusion

As listed by the trial registrant

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

Otitis media Otitis media chronic Otitis media effusion

How to take part

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

  1. The places running it

    1 site. 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

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

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