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A Pocket-Sized MRI for strokes? new device put to the test

NCT ID NCT07751328

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial evaluates the safety and feasibility of a portable, low-field MRI device called Axana for imaging the brain in people with suspected stroke. Researchers will compare scans from the Axana device with standard hospital MRI scans in 60 adults, including healthy volunteers and stroke patients. The goal is to see if the portable device can produce usable images quickly and safely at the bedside, which could speed up stroke diagnosis and treatment.

What this could mean

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

Active substance
Axana portable MRI device
What this could lead to
If successful, this portable MRI could enable faster, bedside stroke diagnosis, potentially improving outcomes in emergency and remote settings.
What could go wrong
This is an early feasibility study with a small number of participants. The device may not match the image quality of standard MRI, and technical failures or usability issues could limit its use.

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

60 people

The number who actually took part.

Started

Jul 2024

Finished

Sep 2025

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

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: Healthy Participants: * Adults aged 18 years or older. * Able to undergo an in-hospital MRI scan. * Able to provide informed consent. * Head size considered suitable for scanning with the Wellumio Axana brain scanner. Hospital Patients: * Adults aged 18 years or older. * Presenting to hospital with an acute neurological deficit suspected to be stroke within 24 hours of symptom onset. * Clinical and radiological diagnosis of stroke, including ischemic stroke, haemorrhagic stroke, or subarachnoid haemorrhage. * Able to undergo an in-hospital MRI scan. * Up to 72 hours post-acute stroke. * Able to provide written informed consent or, where this is not possible, informed consent provided by a legally authorised representative. * Head size considered suitable for scanning with the Wellumio Axana brain scanner. Exclusion Criteria: General: * Pregnant or breastfeeding. * Contraindication to neuroimaging, including any condition that prohibits MRI. * Presence of an implanted electro-stimulating device in the head or neck. * Presence of a large metallic craniofacial implant, such as a bone fixation plate or mesh. Small metallic objects, such as aneurysm coils, are acceptable. * Presence of an intracranial pressure monitor or another similar sensor that may compromise placement of the investigational device. * Inability to wear the investigational device, including because of scalp skin lesions or previous intracranial surgery. * Unable to lie still for the duration of the scan. * Any other condition or symptom that, in the investigator's judgement, prevents participation in the study. * Unable to provide informed consent and, where applicable, consent cannot be obtained from a legally authorised representative. Healthy Participants: * History of a neurological condition, including brain tumour, previous stroke, or neurological trauma. * Post-study MRI findings indicating a brain condition associated with structural changes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Royal Melbourne Hospital, also known as RMH Parkville

    Melbourne, Victoria, 3052, Australia

More trials for these conditions

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