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

Primary Purpose

Stroke, Healthy

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Microwave technology (Medfield Diagnostics)

About this trial

This is an interventional diagnostic trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Strokeenheten, Södra Älvsborgs Sjukhus
Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology
Strokeenheten, Skaraborgs Sjukhus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers

Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C

To confirm the diagnostic ability of the device using a leave-one-out cross validation method

Occurrence of adverse events

Full Information

NCT ID

NCT02266459

First Posted

October 13, 2014

Last Updated

August 10, 2015

Sponsor

Medfield Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT02266459

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medfield Diagnostics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Healthy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Microwave technology (Medfield Diagnostics)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ability to deliver adequate measurement data

Description

To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke

Time Frame

The procedure will take approximately 15 minutes

Secondary Outcome Measure Information:

Title

To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers

Time Frame

The procedure will take approximately 15 minutes

Title

Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C

Time Frame

The procedure will take approximately 15 minutes

Title

To confirm the diagnostic ability of the device using a leave-one-out cross validation method

Time Frame

The procedure will take approximately 15 minutes

Title

Occurrence of adverse events

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan-Erik Karlsson, MD, PhD

Organizational Affiliation

Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Strokeenheten, Södra Älvsborgs Sjukhus

City

Borås

ZIP/Postal Code

501 82

Country

Sweden

Facility Name

Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology

City

Göteborg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

Strokeenheten, Skaraborgs Sjukhus

City

Skövde

ZIP/Postal Code

541 42

Country

Sweden

12. IPD Sharing Statement

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

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