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Portable helmet scanner aims to spot brain bleeds in minutes

NCT ID NCT06999122

Diagnosis Sponsor: EMVision Medical Devices Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests a new portable brain scanner designed to quickly detect bleeding in the brain (hemorrhagic stroke) using harmless radio waves. The helmet-like device could offer a faster, more accessible alternative to CT or MRI scans in emergency settings. Researchers will enroll 300 adults with suspected stroke to see if the scanner can accurately identify brain bleeds within 15 minutes.

What this could mean

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

Active substance
EMVision emu™ Brain Scanner, a portable device that uses ultra-high frequency radio waves to scan the brain
What this could lead to
If accurate, this portable scanner could speed up stroke diagnosis, especially where CT or MRI machines are not readily available, potentially leading to faster treatment and better outcomes.
What could go wrong
This is an early test of the device's accuracy. It may not meet the sensitivity and specificity targets, and its performance could vary in real-world emergency settings.

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 300 people

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

Started

Mar 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

300 subjects across two study arms

Ages

22 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. Adults ≥22 years of age 2. Observable acute neurological deficit suspected to be stroke and within 24 hours of symptom onset 3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient 4. CT or MRI brain imaging following clinical evaluation per standard of care 5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner - Exclusion Criteria: 1. Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis) 2. In-patient for a neurological condition prior to suspected stroke onset 3. In-patient in intensive care unit prior to suspected stroke onset 4. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography 5. Presence of any implanted electro-stimulating devices in the head and neck 6. Presence of any metallic implants in the cranial vault or surrounding bones/tissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable) 7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device 8. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.) 9. Unable to lie still for the duration of the scan 10. Pregnant or breastfeeding 11. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -

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Conditions

The condition(s) this trial relates to.

hemorrhagic stroke stroke disorder

As listed by the trial registrant

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

Hemorrhagic stroke Stroke

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Mayo Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Memorial Hermann Memorial City Medical Center

    RECRUITING

    Houston, Texas, 77024, United States

  • Mount Sinai Health System

    RECRUITING

    New York, New York, 10029, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UTHealth

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

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