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

NCT ID: NCT05745051

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

CVAid Flow

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cvaid Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oren Dror

Role: CONTACT

+972 54-922-5676

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ruth Valdman

Role: primary

972549577137

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0091-22-SZMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.