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New scanner could spot dangerous brain bleeds without radiation

NCT ID NCT04893837

Diagnosis Sponsor: University of Alabama at Birmingham 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a portable device called the Infrascanner that uses light to check for expanding brain bleeds in people with traumatic brain injury. About 400 participants who had a head injury and a brain bleed seen on a CT scan were monitored hourly with the scanner. The goal was to see if the device could quickly and accurately detect when a bleed was getting worse, potentially reducing the need for repeated CT scans.

What this could mean

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

Active substance
Infrascanner (a handheld near-infrared device)
What this could lead to
If successful, this device could help doctors spot worsening brain bleeds quickly and safely without repeated CT scans.
What could go wrong
This is a completed study, but the device may not be accurate enough to replace CT scans in all cases, and results may vary across different hospitals.

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

399 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

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

This study will enroll up to 440 patients over 14 months, at 10 trauma centers. Currently, there are no high quality published datasets or literature to document the mean or variability in time to the detection of hematoma expansion that could be used for meaningful sample size projections. Therefore, this study has been designed to provide reasonable estimates of the future study outcomes.

Ages

15 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: 1. Age 15 or older 2. Admission CT Scan shows intracranial hemorrhage 3. Glasgow Coma Scale less than 15 4. Neurosurgery service determines initial care is nonoperative 5. Admitted for observation for TBI, to either step-down unit or intensive care unit Exclusion Criteria: 1. Inability to provide informed consent or lack of a legally authorized representative (LAR) 2. Admitted and observed for \>2 hours prior to screening (i.e., has already received second neurological check) 3. Other injuries deemed non-survivable 4. Diagnosed with hemorrhagic shock or receives a large volume transfusion (\>3 units of any blood product within any 1 hour) 5. Planned surgical interventions/ procedures during study period (before the second CT scan) 6. Known prisoner

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic hepatitis, infectious canine traumatic brain injury

As listed by the trial registrant

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

Brain injuries, traumatic

Contacts and locations

Locations

  • UAB Hospital

    Birmingham, Alabama, 35233, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

More trials for these conditions

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