To assess the safety and feasibility of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
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.
Royal Melbourne Hospital, also known as RMH Parkville
Melbourne, Victoria, Australia
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
Time frame: 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
Time frame: During each Axana scanning session
Time Required to Complete an Axana Scan
Elapsed time, measured in minutes, required to complete an Axana scan
Time frame: During each Axana scanning session
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.
Time frame: 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
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
Repeatability of Axana scan findings assessed by comparing repeated Axana scans acquired from the same participant during the same scanning session
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 During the same Axana scanning session