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

NCT07751328 | Completed DMC

• 1 other identifier: TNRA 2303-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Acute Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  During each Axana scanning session

• Time Required to Complete an Axana Scan

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

  During each Axana scanning session

Secondary Outcomes (3)

• User-Reported Usability of the Axana Device

  Immediately after each Axana scanning session

• Agreement Between Axana and Hospital MRI Findings

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

• Within-Participant Repeatability of Axana Scans

  Day 1 During the same Axana scanning session

Study Arms (2)

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.

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.

Diagnostic Test: Axana Scan and MRI

Interventions

Axana Scan and MRI DIAGNOSTIC_TEST

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

Control Arm: 10 healthy controls; Test Arm: 50 stroke subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wellumio R&D Australia Pty Ltd: lead

Study Sites (1)

Royal Melbourne Hospital, also known as RMH Parkville

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bruce Campbell, PHD

  Melbourne Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-part, single-centre, feasibility study of the Wellumio 'Axana' 0.1T brain scanning device in subacute stroke patients.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: August 7, 2026
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)