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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266459
• Other study ID #: MF04
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: August 10, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Medfield Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	Strokeenheten, Södra Älvsborgs Sjukhus	Borås
Sweden	Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology	Göteborg
Sweden	Strokeenheten, Skaraborgs Sjukhus	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Medfield Diagnostics

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C		The procedure will take approximately 15 minutes	No
Secondary	To confirm the diagnostic ability of the device using a leave-one-out cross validation method		The procedure will take approximately 15 minutes	No
Secondary	Occurrence of adverse events		24 hours	Yes