The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
NCT ID: NCT05745051
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-11-08
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Age≥18
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cvaid Medical
INDUSTRY
Responsible Party
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Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0091-22-SZMC
Identifier Type: -
Identifier Source: org_study_id
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