Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke

Completed

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Microwave technology (Medfield Diagnostics) Device
    Intervention Desc: 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.

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ability to deliver adequate measurement data The procedure will take approximately 15 minutes No
Secondary To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers The procedure will take approximately 15 minutes No
Secondary Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C The procedure will take approximately 15 minutes No
Secondary To confirm the diagnostic ability of the device using a leave-one-out cross validation method The procedure will take approximately 15 minutes No
Secondary Occurrence of adverse events 24 hours Yes

Sponsors