Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001377426
Ethics application status
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Approved
Date submitted
Help: Date submitted
25/11/2025
Date registered
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9/12/2025
Date last updated
Help: Date last updated
17/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/12/2025
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Feasibility, safety, and usability assessment of the Wellumio Axana portable magnetic resonance device for diagnosis of stroke
Scientific title
Feasibility, safety, and usability assessment of the Wellumio ‘Axana’ 0.1T portable magnetic resonance imaging device for the diagnosis of stroke in the hospital setting.
Additional trial identifiers [1] 316025 0
CT-2024-CTN-02919-1
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stroke 339874 0
Condition category
Condition code
Stroke 336105 336105 0 0
Ischaemic
Stroke 336106 336106 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Use of a portable (100kg) ultra-low-field (0.1 Tesla) magnetic resonance device for the diagnosis of stroke and differentiation of stroke type
- The 'Axana' device is a portable ~100kg ultra-low-field magnetic resonance device that utilises a fixed magnet Aubert ring that is optimised to provide brain coverage. This magnet ring creates a non-homogenous B0 magnetic field, and when coupled with radio frequency generators at specific points around the periphery, allow for a quadrant based spatial information for diagnosis of stroke. This device is low noise, and low energy requiring due to not requiring pulse gradient coils or active cooling.
- This device will be operated by one to two research nurses who have undergone training with the sponsor for operation of the device, supported by a technical support line hosted by the Wellumio, Ltd company.
- The face to face training was undertaken by all primary participating research nurses with a train-the-trainer model for other participating research team members via face-to-face and supervised operation of the device. The initial training was undertaken by the Wellumio, Ltd company representatives 1-2 week prior to commencement of the trial.
- The 'Axana' device scan will be completed two consecutive times for participants with stroke, and 3 scans (two consecutive, one calibration, then the final scan) for healthy participants. These last approximately 9-minutes per scan.
- During scanning, all included participants have information obtained for head position, movement, and tolerance that is recorded to determine the potential fidelity of the final imaging outcome. Ongoing optimisation of the headboard, workflow, and patient positioning will be undertaken during the study to improve the patient experience.
Intervention code [1] 332637 0
Diagnosis / Prognosis
Description of the comparator or control
Conventional Magnetic Resonance imaging (MRI) completed within 6 hours of portable scan episode. Scanning sequences: healthy controls - diffusion weighted imaging (DWI), and fluid attenuated inversion recovery (FLAIR); and stroke patients with DWI, FLAIR, T2-weighted, T1-weighted, plus susceptibility-weighted imaging (SWI) and either time-of-flight magnetic resonance (MR) angiography or MR perfusion.
Control group
Active

Outcomes
Primary outcome [1] 343643 0
To assess the safety (adverse events) of the Wellumio ‘Axana’ device in the hospital setting with healthy controls and patients.
Timepoint [1] 343643 0
Safety assessed from time point 0 (time of scanning) to 24-hours post-scan procedure.
Primary outcome [2] 343713 0
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.
Timepoint [2] 343713 0
Feasibility assessed at time point 0 (scanning time)
Primary outcome [3] 343714 0
Technical stability (faulty components) of the Wellumio ‘Axana’ device in the hospital setting with healthy controls and patients.
Timepoint [3] 343714 0
Assessed at time point 0 (scanning time) for each patient
Secondary outcome [1] 455031 0
Usability of the 'Axana' device
Timepoint [1] 455031 0
Usability surveys completed at the midpoint and end of the overall study period. These timepoints did not represent individual participant follow-up.
Secondary outcome [2] 455032 0
Investigate the reliability of scans acquired with the Axana device within and between participants.
Timepoint [2] 455032 0
Assessed post collection of all study scans- approximately 3-6-months post last participant recruited
Secondary outcome [3] 455370 0
Investigate the reproducibility of scans acquired with the Axana device within and between participants.
Timepoint [3] 455370 0
Assessed post collection of all study scans - approximately 3-6-months post last participant recruited

Eligibility
Key inclusion criteria
Healthy participants
1. Adults greater than or equal to 18 years of age.
2. The participant is able to have an in-hospital MRI scan.
3. Ability to provide informed consent.
4. Head size deemed suitable for scanning with the Wellumio ‘Axana’ brain scanner.

Hospital patients
1. Adults greater than or equal to 18 years of age.
2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 24 hours of symptom onset.
3. Clinical and radiological diagnosis of a stroke (Ischaemic and intra-cranial haemorrhagic including subarachnoid and Subdural haematomas).
4. The patient is able to have an in-hospital MRI scan.
5. The participant is up to 72 hours post-acute stroke.
6. Consent:
a. Ability to provide informed consent. Participants will provide written
informed consent.
b. Where a) is not possible, consent from a legal authorized representative will be obtained.
7. Head size deemed suitable for scanning with the Wellumio ‘Axana’ brain scanner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
General
- Inability to provide consent.
- Pregnant or breastfeeding.
- Contraindication to neuroimaging, such conditions that prohibits MRI.
- Presence of any implanted electro-stimulating devices in the head and neck.
- Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc (Note that small metallic objects, such an aneurysm coils etc, are acceptable).
- Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
- Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc).
- Unable to lie still for the duration of the scan.
- Any other condition or symptoms preventing the participant from
entering the study, according to the investigator ´s judgment.

Healthy Controls
- History of neurological conditions (i.e. tumour, prior stroke, trauma etc).
- Post study MRI findings of brain conditions causing structural changes.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To assess the safety:
- The proportion of cases with any adverse events within 24 hours of being assessed with the ‘Axana’ device will be estimated.
- The proportion of cases where the ‘Axana’ device develops any defective components, performance failures, deficiencies or technical failures during the study period that may result in potential harm to the
participant.

To assess the feasibility:
- The proportion of cases where trained study staff are able to operate
the ‘Axana’ device to acquire an image without technical fault in a timely manner (no longer than 20min) will be estimated.

To assess the Usability:
- The proportion of cases where the study device was classified as ‘usable’ will be estimated. To assess the agreement between Axana device and hospital MRI, inter device agreement will be estimated using Cohen’s Kappa over predefined clinical categories of ischemic stroke, haemorrhagic stroke, or no significant finding.

To assess the Reliability and Reproducibility:
- To estimate reliability, inter-rater agreement in interpreting the image by two independent clinicians will be estimated using Cohen’s Kappa over predefined clinical categories of ischemic stroke, haemorrhagic stroke, or no significant finding.
- To estimate reproducibility, an agreement on imaging outcome between two repeated images taken on the same participant will be estimated using Cohen’s Kappa over predefined clinical categories of ischemic stroke, haemorrhagic stroke, or no significant finding.

The safety data for the device will be independently reviewed by an external panel of trial experts to provide comment on the study and device performance. The data will be reviewed continuously with any adverse events reported to the safety committee.

This feasibility study is descriptive in nature. All baseline characteristics will be summarized descriptively. All endpoints of interest for each study phase will be presented as estimates with respective 95% confidence intervals. Categorical characteristics/endpoints will be summarized using counts, frequencies and percentages. Agreement will be assessed using intra-class correlation coefficient and Cohen's Kappa between the ‘Axana’ device scans and the in-hospital MRI findings for findings of ‘stroke’ or ‘no stroke’. All other analysis will be performed using appropriate methodologies

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2025
Date of last participant enrolment
Anticipated
28/02/2026
Actual
9/03/2026
Date of last data collection
Anticipated
1/03/2026
Actual
15/06/2026
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28829 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 45065 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 320628 0
Charities/Societies/Foundations
Name [1] 320628 0
Australian Stroke Alliance
Country [1] 320628 0
Australia
Funding source category [2] 320630 0
Commercial sector/Industry
Name [2] 320630 0
Wellumio, Ltd
Country [2] 320630 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Wellumio, Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 323250 0
Charities/Societies/Foundations
Name [1] 323250 0
Australian Stroke Alliance
Address [1] 323250 0
Country [1] 323250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319169 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 319169 0
Ethics committee country [1] 319169 0
Australia
Date submitted for ethics approval [1] 319169 0
Approval date [1] 319169 0
31/07/2024
Ethics approval number [1] 319169 0
HREC/105831/MH-2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146478 0
Prof Stephen Davis
Address 146478 0
Melbourne Brain Centre, Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC 3050
Country 146478 0
Australia
Phone 146478 0
+61 417 245 946
Fax 146478 0
Email 146478 0
[email protected]
Contact person for public queries
Name 146479 0
Gyan Barik
Address 146479 0
Wellumio, 470 St Kilda Rd, Melbourne VIC 3004
Country 146479 0
Australia
Phone 146479 0
+61 434 216 485
Fax 146479 0
Email 146479 0
[email protected]
Contact person for scientific queries
Name 146480 0
Dr James Barker
Address 146480 0
Melbourne Brain Centre, Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC 3050
Country 146480 0
Australia
Phone 146480 0
+61 432 397 350
Fax 146480 0
Email 146480 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.