Acute Stroke, Hemorrhagic Stroke, Ischemic Stroke, Stroke
Conditions
Keywords
Portable imaging, MRI scanner, Acute stroke detection, Stroke Imaging, Low field MRI, ER stroke diagnosis
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAxana Scan and MRI
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.
Sponsors
Wellumio R&D Australia Pty Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A two-part, single-centre, feasibility study of the Wellumio 'Axana' 0.1T brain scanning device in subacute stroke patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-Related Adverse Events | 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 | 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 | During each Axana scanning session | Elapsed time, measured in minutes, required to complete an Axana scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User-Reported Usability of the Axana Device | Immediately after each Axana scanning session | 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. |
| 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 | Agreement between findings obtained using the Axana device and findings from the hospital MRI examination performed on the same day |
| Within-Participant Repeatability of Axana Scans | Day 1 During the same Axana scanning session | Repeatability of Axana scan findings assessed by comparing repeated Axana scans acquired from the same participant during the same scanning session |
Countries
Australia
Contacts
STUDY_DIRECTORBruce Campbell, PHD
Melbourne Health
Outcome results
None listed