The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

Conditions
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Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Cardiovascular, Stroke Hemorrhagic

Intervention / Treatment
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* Diagnostic Test: CVAid Flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT) Age≥18 Exclusion Criteria: Intubated patients upon arrival Time from stroke symptoms onset > 24h Patients post treatment (tPA of EVT) Patient in acute psychosis state Patients who do not speak Hebrew as their mother tongue

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke<br>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. | Diagnostic Test: CVAid Flow<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | after 24 hours |