Ischemic Stroke
Conditions
Brief summary
cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.
Interventions
DEVICE1st Reading
The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.
DEVICE2nd Reading
The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.
Sponsors
Heuron Inc.
Study design
Observational model
CASE_CROSSOVER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 19 years old * Brain non-contrast CT, CT perfusion and CT angiography acquired * Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography * Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
Exclusion criteria
* Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of medical team compared with/without cELVO | Within 2 weeks after completion of reading | Sensitivity and specificity of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of medical team compared with/without cELVO | Within 2 weeks after completion of reading | Accuracy of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO |
| ROC Curve for medical team compared with/without cELVO | Within 2 weeks after completion of reading | ROC Curve of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO |
| AUC values for medical team compared with/without cELVO | Within 2 weeks after completion of reading | AUC values of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO |
| Sensitivity and specificity of each reader compared with/without cELVO | Within 2 weeks after completion of reading | Sensitivity and specificity of determining large vessel occlusion of each reader when using cELVO compared to not using cELVO |
| Sensitivity and specificity of cELVO | Within 2 weeks after completion of reading | Sensitivity and specificity of cELVO in diagnosis of large vessel occlusion based on golden standards |
Countries
South Korea
Outcome results
None listed