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New Light-Based device could spot brain bleeds in minutes without a CT scan

NCT ID NCT07338383

Diagnosis Sponsor: The Geneva Foundation Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a portable device that uses near-infrared light to find brain bleeds in people with traumatic brain injury. The goal is to see if it works as well as a CT scan, especially in places like battlefields or rural areas where CT machines aren't available. About 80 adults with head injuries will be scanned with the device, and the results will be compared to their CT scans. If successful, this tool could help doctors diagnose and treat brain bleeds faster, potentially saving lives and preventing long-term damage.

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 80 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

Access to the proposed population includes a mixture of 15% active-duty military and/or VA patients and 85% civilians from central/southern Texas, including the 22 surrounding counties that are receiving trauma care at Brooke Army Medical Center. Daily review of the Trauma census will be conducted to review eligible patients. This screening tool will help determine, predict, and address challenges to recruitment.

Ages

18 to 89 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: * 18 to 89 years of age * Able to provide written informed consent either by self or legally authorized representative * Received head CT imaging on admission * Able to complete at least one NIRD-HI scan within 4 hours of head CT * Non-operative management planned Exclusion Criteria: * Presence of penetrating or non-survivable injuries * Hemorrhagic shock or large volume transfusion \[\>3 units of any blood product within 1 hour of scan\] * Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement * Presence of heat tattoos or intracranial metal fixtures * Cervical injury prolonging C-spine collar * Known prisoners or wards of state * Any condition or finding that makes the patient unsuitable for image acquisition in the Investigator's opinion

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracerebral hemorrhage Intracranial Hemorrhages traumatic brain injury

As listed by the trial registrant

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

Combat casualty care Intracranial hemorrhages Point of care Traumatic brain injury

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

  • Brooke Army Medical Center

    San Antonio, Texas, 78234, United States

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