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

NCT05745051 | Unknown DMC

• 1 other identifier: 0091-22-SZMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic; Stroke, Cardiovascular; Stroke Hemorrhagic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Device operational performance

  At admission

• Device operational performance

  after 24 hours

Study Arms (1)

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.

Diagnostic Test: CVAid Flow

Interventions

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).

Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT)
• Age≥18

You may not qualify if:

• 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

Sponsors & Collaborators

• Cvaid Medical: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Myocardial Infarction; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Oren Dror

CONTACT

+972 54-922-5676; oren@cvaidmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: November 8, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)