An interventional study of Microwave technology (Medfield Diagnostics) in Stroke and Healthy, sponsored by Medfield Diagnostics. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-11.
Sponsored by Medfield Diagnostics · Not applicable, Interventional, and Diagnostic
This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.
The main purpose of the study is to evaluate the ability of the Microwave Technology to deliver adequate measurement data.
After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After subject enrollment the microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is \< 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.
The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation method with the CT diagnosis as ground truth. Microwave signals are sensitive to the dielectric parameters of the investigated object. In biological matter this is often related to amount of water. Brain tissue has different dielectric properties from blood. The physiological changes inside the brain that occurs as a result of a stroke will change the dielectric parameters.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 165 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Medfield Diagnostics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
(Group A)
(Group B)
(Group C)
Exclusion Criteria:
(Group A+B)
(Group C)
A microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is \< 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.
Ability to deliver adequate measurement data
To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke
Time frame: The procedure will take approximately 15 minutes
To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers
Time frame: The procedure will take approximately 15 minutes
Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C
Time frame: The procedure will take approximately 15 minutes
To confirm the diagnostic ability of the device using a leave-one-out cross validation method
Time frame: The procedure will take approximately 15 minutes
Occurrence of adverse events
Time frame: 24 hours
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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