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New 5-Minute brain scanner could speed up ER triage

NCT ID NCT07490418

Diagnosis Sponsor: B&B srl 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new device called TES HT100 that uses low-power electromagnetic waves to screen for brain injuries in adults coming to the emergency room with mild head trauma or certain neurological symptoms. The device is non-invasive, takes about 5 minutes, and gives a simple yes/no result. Researchers will compare its accuracy to standard head CT scans to see if it can help doctors decide who needs further testing.

What this could mean

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

Active substance
Temnographic Brain Screening Examination (TES HT100 device)
What this could lead to
If successful, this device could provide a quick, non-invasive way to screen for brain injuries in the emergency room, potentially reducing unnecessary CT scans and speeding up patient care.
What could go wrong
This is an early validation study, so the device may not prove accurate enough to replace CT scans. It is also only tested in adults with mild symptoms, so 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.

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 850 people

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

Started

Dec 2024

Expected to finish

Jul 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.

Ages

18 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: * Age greater than 18 years * Provision of informed consent * Presentation to the Emergency Department with mild head injury, or * Presentation to the Emergency Department for non-traumatic neurological symptoms and not in a critical condition, including: * syncope * spatial disorientation and/or loss of balance * speech disturbance and/or facial hemi-paresis * visual alterations * memory loss and/or confusional state Exclusion Criteria: * Age less than 18 years * Pregnant women * Metal plates or metal prostheses installed in the skull cap * Severe head trauma and/or extensive lacerated-contused areas * Critical condition * Visible skull fracture * Failure or inability to provide signed informed consent

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Conditions

The condition(s) this trial relates to.

Brain Concussion brain injury Craniocerebral Trauma delirium Emergencies traumatic brain injury vision disorder

As listed by the trial registrant

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

Intracranial lesions Mild traumatic brain injury Neurological symptoms not related to head trauma

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

  • Pineta Grande Hospital

    RECRUITING

    Castel Volturno, CE, 81030, Italy

More trials for these conditions

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