The stage-two clinical trial, which follows the successful completion of stage-one trial in 30 healthy volunteers, is designed to enrol up to 150 acute stroke and stroke mimic patients, across major comprehensive stroke centres in Australia
Australian medical device company EMVision Medical Devices has initiated the second stage of its multi-site clinical trial evaluating its first-generation portable brain scanner.
The stage-two clinical trial, which follows the successful completion of the stage-one trial in 30 healthy volunteers, is designed to enrol up to 150 acute strokes and stroke mimic patients.
It will be conducted across major comprehensive stroke centres in Australia, including Liverpool Hospital, Royal Melbourne, and Princess Alexandra.
EMVision said that each site has the necessary stroke patient population and a dedicated research team to support the planned enrolment process.
The stage-two study will be initiated with Liverpool Hospital as the first site, followed by Royal Melbourne in June and Princess Alexandra after a few weeks.
EMVision CEO Ron Weinberger said: “We have now achieved the critical and noteworthy phase of acquiring data from suspected stroke patients in the acute setting.
“Significant preparation and positive collaboration between the EMVision team and hospital staff has been underway to ensure the next phase of our multi-site clinical trials is set up for success.”
In February this year, EMVision announced that the pre-validation phase of the clinical trial is on track, with all 30 participants being successfully enrolled on the first stage of the clinical trial.
The healthy baseline volunteers received a scan with the EMVision first-generation portable brain scanner, alongside an MRI, at Liverpool Hospital.
EMVision said that the insights from healthy volunteers in stage-one clinical trials have contributed to important usability, workflow, and technical improvements to the device.
It enabled the operators to perform EMVision scans in even shorter windows, while dealing with time-sensitive medical emergencies, such as acute stroke.
Weinberger added: “A key part of this preparation has been a keen focus on strategies and support to enable brisk patient recruitment. We are grateful to our clinical collaborators for their enthusiasm and commitment.
“We have taken the technical and usability information from Stage 1 and refined our device for Stage 2 and although the modifications are not major, they will result in significant improvements in performance.”