ClinicalTrials.gg
CompletedNCT07751328Updated Aug 7, 2026

Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable MRI Device

An interventional study of Axana Scan and MRI in Stroke, Acute Stroke and Ischemic Stroke, sponsored by Wellumio R&D Australia Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Wellumio R&D Australia Pty Ltd · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 121 studies in Stroke with a site in Australia — 21 open to participants now, 28 under way, 10 of them phase 3. Stroke · Australia.

Enrollment
89th of 107
60 · median 585
Started
2024
with 7 others
No phase
28 of 121
6 open now
Registered
110th of 121
by date

Among the 121 studies in Stroke with a site in Australia, this one is the 89th largest by enrollment of the 107 interventional ones that give a count, is one of 8 that started in 2024, is one of 28 with no phase, and was the 110th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

21 of the 121 studies in Stroke with a site in Australia are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

To assess the safety and feasibility of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.

Read the detailed description

This study aims to identify if the Wellumio 'Axana' device, a portable 0.1T MRI, is feasible, safe and reliable for use in the hospital setting.

Primary Objective

- To assess the safety (adverse events) and feasibility (ability to acquire a scan, in a timely manner without technical fault) of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.

Secondary Objective

  • Assess usability of the Axana device.
  • Acquire physiological data from healthy controls and hospital patients with the 'Axana' device, and hospital MRI scanners.
  • Investigate the repeatability and reproducibility of scans acquired with the Axana device within and between participants.
03

Conditions studied

  • Stroke
  • Acute Stroke
  • Ischemic Stroke
  • Hemorrhagic Stroke

Keywords

  • Portable imaging
  • MRI scanner
  • Acute stroke detection
  • Stroke Imaging
  • Low field MRI
  • ER stroke diagnosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy Participants:

  • Adults aged 18 years or older.
  • Able to undergo an in-hospital MRI scan.
  • Able to provide .
  • 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

Exclusion Criteria:

General:

  • Pregnant or breastfeeding.
  • 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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Control Arm: 10 healthy controls

    Healthy controls with no brain structural changes will be scanned up to 3 times in one session with the 'Axana' device, and have a concurrent hospital brain MRI scan.The hospital MRI performed should consist of a minimum of a T2, FLAIR, ADC, DWI and GRE.

    Diagnostic Test: Axana Scan and MRI

  • Experimental
    Test Arm: 50 stroke subjects

    Patients admitted to hospital with a stroke will be scanned with the 'Axana' device during their hospital stay. Patients will be booked in for a hospital MRI scan as per standard in-hospital processes. On the day of the MRI scan, patients will have two 'Axana' device scans (Scan 1\& 2). These scans must all happen on the same day and no strict order or scans are required. There must be no more than 6 hours between the hospital MRI and 'Axana' scans. The hospital MRI performed should consist of a minimum of a T2, FLAIR, ADC, DWI and GRE.

    Diagnostic Test: Axana Scan and MRI

Interventions

  • Diagnostic testAxana Scan and MRI

    Patients will be booked in for a hospital MRI scan as per standard in-hospital processes. On the day of the MRI scan, patients will have two 'Axana' device scans (Scan 1 \& 2). These scans must all happen on the same day and no strict order or scans are required. There must be no more than 6 hours between the hospital MRI and 'Axana' scans. The hospital MRI performed should consist of a minimum of a T2, FLAIR, ADC, DWI and GRE.

    Also known as: Axana Scan, MRI scan

06

What researchers measure

Primary outcomes

  1. Number of Participants With Device-Related Adverse Events

    Number of participants experiencing one or more adverse events considered related to the Axana device or scanning procedure

    Time frame: During the Axana scan and immediately following completion of the scan

  2. Proportion of Axana Scan Attempts Successfully Completed Without Technical Failure

    Proportion of attempted Axana scans successfully completed without a technical fault preventing scan acquisition

    Time frame: During each Axana scanning session

  3. Time Required to Complete an Axana Scan

    Elapsed time, measured in minutes, required to complete an Axana scan

    Time frame: During each Axana scanning session

Secondary outcomes

  1. User-Reported Usability of the Axana Device

    Usability of the Axana device assessed using a post-scan questionnaire completed by the physician or device user. Questionnaire responses were collected throughout enrolment to evaluate user experience and changes associated with increasing familiarity with the device.

    Time frame: Immediately after each Axana scanning session

  2. Agreement Between Axana and Hospital MRI Findings

    Agreement between findings obtained using the Axana device and findings from the hospital MRI examination performed on the same day

    Time frame: Axana and hospital MRI examinations performed on the same day, with no more than 6 hours between examinations

  3. Within-Participant Repeatability of Axana Scans

    Repeatability of Axana scan findings assessed by comparing repeated Axana scans acquired from the same participant during the same scanning session

    Time frame: Day 1 During the same Axana scanning session

07

Study locations

1 site
  • Royal Melbourne Hospital, also known as RMH Parkville
    Melbourne, Victoria 3052, Australia
08

References and documents

Individual participant data

Plan to share: No — The study is a first in man study serving as the basis of RD development and future trials

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2024 to primary completion in Sep 2025, 14 months.

Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 14 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2024
First posted
Aug 7, 2026
StartActual
Jul 1, 2024
Primary completionActual
Sep 30, 2025
CompletionActual
Sep 30, 2025
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07751328
Lead sponsor
Wellumio R&D Australia Pty Ltd
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Jul 1, 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Aug 7, 2026

Study contacts

Bruce Campbell, PHD
study director · Melbourne Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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