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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02266459
• Date of registration: 13/10/2014
• Prospective Registration: No
• Primary sponsor: Medfield Diagnostics
• Public title: Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
• Scientific 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.
• Date of first enrolment: October 2014
• Target sample size: 165
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02266459
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Jan-Erik Karlsson, MD, PhD
• Affiliation: Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Healthy

Intervention(s)

Device: Microwave technology (Medfield Diagnostics)

Primary Outcome(s)

Ability to deliver adequate measurement data [Time Frame: The procedure will take approximately 15 minutes]

Secondary Outcome(s)

Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C [Time Frame: The procedure will take approximately 15 minutes]

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]

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]

Occurrence of adverse events [Time Frame: 24 hours]

Secondary ID(s)

MF04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors