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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Healthy
• Intervention / Treatment: Device: Microwave technology (Medfield Diagnostics)

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 Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Borås, Sweden, 501 82
    • Strokeenheten, Södra Älvsborgs Sjukhus
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology
  • Skövde, Sweden, 541 42
    • Strokeenheten, Skaraborgs Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The procedure will take approximately 15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medfield Diagnostics
• Investigators: Principal Investigator: Jan-Erik Karlsson, MD, PhD, Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (ESTIMATE): October 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MF04