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New brain scanner could spot bleeding in minutes without radiation

NCT ID NCT06828107

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called SENSE that uses low-power electromagnetic pulses to check for bleeding or swelling in the brain after a traumatic injury. Researchers will compare the device's results to standard CT scans in 150 adults, including those with and without brain injuries, as well as healthy volunteers. If accurate, the device could offer a faster, bedside way to diagnose brain bleeding.

What this could mean

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

Active substance
SENSE device (electromagnetic pulse device)
What this could lead to
If successful, this could provide a faster, portable way to detect brain bleeding after head injury, potentially speeding up diagnosis and treatment.
What could go wrong
This is an early-phase study with only 150 participants, so results may not apply to all patients. The device is compared to CT scans, which are the current standard, and may not be as accurate.

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

Jul 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 study population will consist of 3 mutually-exclusive sets of patients and subjects: * TBI patients with intracranial bleeding * TBI patients without intracranial bleeding * Control subjects with normal brain health. Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating clinician and within 24 hours of injury.

Ages

22 years and older

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: * • Male or female adults age 22 and older * Patients with TBI who have a head CT scan obtained in the mobile stroke unit, emergency department, or hospital, ordered by a treating clinician OR control subjects with normal brain health. * For patients with traumatic intracranial hemorrhage, blood is visible on ≥ 3 consecutive axial CT slices. * Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legally authorized representative. * Willingness and ability to comply with schedule for study procedures. Exclusion Criteria: * • Female patients who are pregnant or lactating. * SENSE Device is unable to be placed within 6 hours of a standard of care head CT and within 24 hours of injury. * Open skull fracture (closed skull fracture is not an exclusion). * Metallic intracranial clip, coil, or device (such as metallic ICP monitor). * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE Device monitoring or study participation or may confound the outcome of the study. * Planned placement of an intraventricular catheter prior to study enrollment. * Planned intracranial surgery prior to study enrollment. * Current participation in a medical or surgical interventional clinical trial. * Use of continuous EEG monitoring at the time of enrollment. * Clinical uncertainty about the presence or absence of hemorrhage on the enrolling head CT. * Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI requiring emergency room evaluation, concussion within the previous 6 months, hydrocephalus, intracranial vascular malformation, other structural brain disease, or intracranial surgery. Benign headache disorders (e.g. migraine headache, tension headache), and mild concussion \> 6 months prior to enrollment are not exclusions.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 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

  • MUSC

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • UT Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • UTSA

    RECRUITING

    San Antonio, Texas, 78249, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45209, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32611, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15260, United States

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