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

NCT ID: NCT02266459

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-07-31

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.

Conditions

Stroke; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Microwave technology (Medfield Diagnostics)

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medfield Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan-Erik Karlsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology

Locations

Strokeenheten, Södra Älvsborgs Sjukhus

Borås, Borås, Sweden

Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology

Gothenburg, Göteborg, Sweden

Strokeenheten, Skaraborgs Sjukhus

Skövde, , Sweden

Countries

Sweden

Other Identifiers

MF04

Identifier Type: -

Identifier Source: org_study_id