Stroke, Stroke, Acute, Stroke, Cardiovascular, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCVAid Flow
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).
Sponsors
Cvaid Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of stroke severity classification by CVA-CORE algorithm | At admission | Stroke severity classification will be calculated by the CVA-CORE system algorithm and compared to the imaging results (interpretation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device operational performance | At admission | 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 |
Countries
Israel
Contacts
Primary ContactOren Dror
Outcome results
None listed