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

Not Applicable

Completed

• Conditions: Stroke; Healthy

• Registration Number: NCT02266459
• Lead Sponsor: Medfield Diagnostics

Brief Summary

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ability to deliver adequate measurement data	The procedure will take approximately 15 minutes	To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke

Secondary Outcome Measures

Name	Time	Method
Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C	The procedure will take approximately 15 minutes
To confirm the diagnostic ability of the device using a leave-one-out cross validation method	The procedure will take approximately 15 minutes
Occurrence of adverse events	24 hours
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

Trial Locations

Locations (3)

Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology; 🇸🇪 Göteborg, Sweden

Strokeenheten, Södra Älvsborgs Sjukhus; 🇸🇪 Borås, Sweden

Strokeenheten, Skaraborgs Sjukhus; 🇸🇪 Skövde, Sweden