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NCT07751328Completed

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

Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable Magnetic Resonance Imaging Device The 'Portable MRI Study'

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
24 May 2024
Start date
1 Jul 2024
Primary completion date
30 Sept 2025
Lead sponsor
Wellumio R&D Australia Pty Ltd
Diseases
Stroke
NCT number
NCT07751328

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 1 Jul 2024 to the primary completion date, 30 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • History of a neurological condition, including brain tumour, previous stroke, or neurological trauma.

Other illness

  • Contraindication to neuroimaging, including any condition that prohibits MRI.
  • Any other condition or symptom that, in the investigator's judgement, prevents participation in the study.
  • Post-study MRI findings indicating a brain condition associated with structural changes.

Other

  • General:
  • Pregnant or breastfeeding.
  • Presence of an implanted electro-stimulating device in the head or neck.
  • Unable to lie still for the duration of the scan.
  • Unable to provide informed consent and, where applicable, consent cannot be obtained from a legally authorised representative.
    • Healthy Participants:

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Melbourne Hospital, also known as RMH Parkville
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.