A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW
Status unconfirmed
Conditions studied: Stroke
In brief
CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
Key facts
- Study ID
- NCT06101004
- Run by
- Cvaid Medical
- People needed
- 460
- Starts
- 2023-10-23
- Expected to finish
- 2024-05-30
- Last updated by the study team
- 2023-10-25
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥21 years of age
- With suspected acute stroke at the ED prior to treatment (tPA or EVT)
You may not qualify if…
- Patient intubated upon arrival
- Patient treated with tPA prior to arrival at the ED
- Patients with the following conditions:
- Brain tumors
- Hypoglycemia
- Toxic poisoning
- Seizures
- Sepsis
- Subdural hematoma
- Encephalopathy (uremic, hepatic or other)
- Encephalitis
- Previous stroke with permanent neurological deficit
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Hospital Vall d'Hebron - Neurology — Barcelona, Spain
Full record on ClinicalTrials.gov
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