Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
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|ClinicalTrials.gov Identifier: NCT02266459|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : August 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Healthy||Device: Microwave technology (Medfield Diagnostics)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
- 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.
- Ability to deliver adequate measurement data [ 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 patients diagnosed with Hemorrhagic stroke and Ischemic stroke
- 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 ]
- 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 ]
- Occurrence of adverse events [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266459
|Strokeenheten, Södra Älvsborgs Sjukhus|
|Borås, Sweden, 501 82|
|Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology|
|Göteborg, Sweden, 41345|
|Strokeenheten, Skaraborgs Sjukhus|
|Skövde, Sweden, 541 42|
|Principal Investigator:||Jan-Erik Karlsson, MD, PhD||Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology|