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

Completed · Not applicable

Conditions studied: Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke

In brief

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

Key facts

Study ID

NCT07751328

Run by

Wellumio R&D Australia Pty Ltd

People needed

60

Starts

2024-07-01

Expected to finish

2025-09-30

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Royal Melbourne Hospital, also known as RMH Parkville — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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