The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
CVA-FLOW is a Telestroke mobile software solution that enables the neurologist to remotely assess, on his smartphone, patients suspected with stroke. Real-time, objective, patient-specific data such as images, videos and vocal records of the patient, are acquired by a first responder (CVA-COLLECTOR) at the patient's location. This allows the neurologist to complete the NIH Stroke Scale and independently reach a diagnostic conclusion and treatment plan (CVA-MED).
Shaare Zedek Medical Center
Jerusalem, Israel
RECRUITINGSensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
Time frame: At admission
Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm
Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation).
Time frame: after 24 hours
Device operational performance
The investigator shall assess the use of the device during the operation, and conclude a summary evaluation after the end of the usage. Evaluation items are shown below:Item / evaluation * Usage experience: Simple to operate/difficult to operate * Errors: No errors occurs during the usage/ Errors occurs during the usage * Known safety issues during use of CVA-MED and CVA-COLLECTOR
Time frame: At admission
Device operational performance
The investigator shall assess the use of the device during the operation, and conclude a summary evaluation after the end of the usage. Evaluation items are shown below:Item / evaluation * Usage experience: Simple to operate/difficult to operate * Errors: No errors occurs during the usage/ Errors occurs during the usage * Known safety issues during use of CVA-MED and CVA-COLLECTOR
Time frame: after 24 hours
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