Healthy Clinical Trial
Official title:
A Prospective, Open, Multicenter Study to Evaluate the Performance, Safety and Usability of the Microwave Technology Developed by Medfield Diagnostics When Collecting Measurement Data From Patients With Clinical Signs of Stroke.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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