Evaluating a digital health system for acute ischemic stroke management
A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke
NA · Cvaid Medical · NCT05745051
This study tests a new AI-based software that helps doctors make better decisions for treating patients with acute ischemic stroke to see if it improves their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cvaid Medical (industry) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05745051 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of the CVA-FLOW software device, an AI-based Telestroke system designed to assist medical professionals in triaging patients with acute ischemic stroke. The device utilizes dedicated algorithms to enhance decision-making in emergency settings prior to treatment. By demonstrating its efficacy, the study seeks to support the application for market approval of the CVA-FLOW device, potentially improving patient outcomes in acute stroke care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are suspected of having a hyper-acute stroke upon arrival at the emergency department.
Not a fit: Patients who are intubated upon arrival, have experienced stroke symptoms for more than 24 hours, or are in an acute psychosis state will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance the triage process for acute ischemic stroke patients, leading to timely and effective treatment.
How similar studies have performed: While this approach is innovative, similar studies utilizing AI in stroke management have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jerusalem
- Shaare Zedek Medical Center — Jerusalem, Israel (RECRUITING)
Study contacts
- Study coordinator: Oren Dror
- Email: oren@cvaidmedical.com
- Phone: +972 54-922-5676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Cardiovascular, Stroke Hemorrhagic