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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVAid Flow | Diagnostic Test | 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). |
| 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 |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oren Dror | Contact | +972 54-922-5676 | oren@cvaidmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D009203 | Myocardial Infarction |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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
| after 24 hours |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |