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

Medfield Diagnostics

Status

Completed

Conditions

Healthy

Stroke

Treatments

Device: Microwave technology (Medfield Diagnostics)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02266459

MF04

Details and patient eligibility

About

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.

Full 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.

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

(Group A)

Signed Informed Consent Form
Patient diagnosed (by CT) with ischemic stroke, within 24 hours of stroke onset
Patient should be ≥ 18 years of age

(Group B)

Signed Informed Consent Form
Patient diagnosed (by CT) with hemorrhagic stroke, within 48 hours of stroke onset
Patient should be ≥ 18 years of age

(Group C)

Signed Informed Consent Form
Subject should be ≥ 18 years of age

Exclusion criteria

(Group A+B)

Pregnant or nursing woman
Woman of child bearing potential and not taking adequate contraceptive precautions
Patient that has already received thrombolytic treatment
Patient participating in any other clinical study that could interfere with the result in the present study
Patient diagnosed with a condition associated with risk of poor protocol compliance
Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrollment

(Group C)

Pregnant or nursing woman
Woman of child bearing potential and not taking adequate contraceptive precautions
Subject participating in any other clinical study that could interfere with the result in the present study
Any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment
Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment