StrokeNCT07751328
Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable MRI Device
A study testing Axana Scan and MRI in people with Stroke and Acute Stroke, run by Wellumio R&D Australia Pty Ltd at 1 site in Australia.
Trial summary
To assess the safety and feasibility of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute Stroke, Ischemic Stroke
- What is being tested?
- Axana Scan and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Melbourne Hospital, also known as RMH Parkville
Melbourne, Victoria, 3052
About this study
Official title: Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable Magnetic Resonance Imaging Device The 'Portable MRI Study'
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.
- Conditions
- Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Axana Scan and MRI
- Keywords
- Portable imaging, MRI scanner, Acute stroke detection, Stroke Imaging, Low field MRI, ER stroke diagnosis
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axana Scan and MRIDiagnostic test
Also called Axana Scan, MRI scan
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: 10 healthy controls | Active comparator | 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. Receives: Diagnostic Test: Axana Scan and MRI |
| Test Arm: 50 stroke subjects | Experimental | 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. Receives: Diagnostic Test: Axana Scan and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the Axana scan and immediately following completion of the scan
Proportion of Axana Scan Attempts Successfully Completed Without Technical Failure
Proportion of attempted Axana scans successfully completed without a technical fault preventing scan acquisition
Measured: During each Axana scanning session
Time Required to Complete an Axana Scan
Elapsed time, measured in minutes, required to complete an Axana scan
Measured: During each Axana scanning session
Secondary outcomes (3)
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.
Measured: Immediately after each Axana scanning session
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
Measured: Axana and hospital MRI examinations performed on the same day, with no more than 6 hours between examinations
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
Measured: Day 1 During the same Axana scanning session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A two-part, single-centre, feasibility study of the Wellumio 'Axana' 0.1T brain scanning device in subacute stroke patients.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellumio R&D Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Campbell, PHD, Study director, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751328
- Sponsor's protocol ID
- TNRA 2303-1
- Status last verified
- Aug 2026
- First submitted
- 24 May 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is a first in man study serving as the basis of RD development and future trials
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable Magnetic Resonance Imaging Device The 'Portable MRI Study'
- ClinicalTrials.gov ID
- NCT07751328
- Acronym / sponsor ID
- TNRA 2303-1
- Conditions
- Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- Portable imaging, MRI scanner, Acute stroke detection, Stroke Imaging, Low field MRI, ER stroke diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wellumio R&D Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and feasibility of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-part, single-centre, feasibility study of the Wellumio 'Axana' 0.1T brain scanning device in subacute stroke patients.
| Arm | Type | Receives |
|---|---|---|
| Control Arm: 10 healthy controls | Active comparator | Diagnostic Test: Axana Scan and MRIHealthy 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. |
| Test Arm: 50 stroke subjects | Experimental | Diagnostic Test: Axana Scan and MRIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Adults aged 18 years or older.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axana Scan and MRIAlso: Axana Scan, MRI scanPatients 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 | Control Arm: 10 healthy controls, Test Arm: 50 stroke subjects |
Primary outcome
Number of Participants With Device-Related Adverse Events
Time frame: During the Axana scan and immediately following completion of the scan
Number of participants experiencing one or more adverse events considered related to the Axana device or scanning procedure
Proportion of Axana Scan Attempts Successfully Completed Without Technical Failure
Time frame: During each Axana scanning session
Proportion of attempted Axana scans successfully completed without a technical fault preventing scan acquisition
Time Required to Complete an Axana Scan
Time frame: During each Axana scanning session
Elapsed time, measured in minutes, required to complete an Axana scan
3 secondary outcomes
User-Reported Usability of the Axana Device
Time frame: Immediately after each Axana scanning session
Agreement Between Axana and Hospital MRI Findings
Time frame: Axana and hospital MRI examinations performed on the same day, with no more than 6 hours between examinations
Within-Participant Repeatability of Axana Scans
Time frame: Day 1 During the same Axana scanning session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. The study is a first in man study serving as the basis of RD development and future trials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Campbell, PHD study director
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axana Scan and MRI in people with Stroke and Acute Stroke, run by Wellumio R&D Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-Related Adverse Events (time frame: During the Axana scan and immediately following completion of the scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.