The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
NCT05745051 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-08-30
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.
Conditions
- Stroke
- Stroke, Acute
- Stroke, Ischemic
- Stroke, Cardiovascular
- Stroke Hemorrhagic
Interventions
- DIAGNOSTIC_TEST
-
CVAid 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 & Collaborators
-
Cvaid Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-08
- Primary Completion
- 2023-10-30
- Completion
- 2023-11-30
Countries
- Israel
Study Locations
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