Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: 1st Reading
* Device: 2nd Reading


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive group<br>A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography | Device: 1st Reading<br>* The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.<br>* Other names: Stage 1;Device: 2nd Reading<br>* The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.<br>* Other names: Stage 2;|
| Negative group<br>A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography | Device: 1st Reading<br>* The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.<br>* Other names: Stage 1;Device: 2nd Reading<br>* The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.<br>* Other names: Stage 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of medical team compared with/without cELVO | Sensitivity and specificity of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO | Within 2 weeks after completion of reading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of medical team compared with/without cELVO | Accuracy of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO | Within 2 weeks after completion of reading | 
| ROC Curve for medical team compared with/without cELVO | ROC Curve of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO | Within 2 weeks after completion of reading | 
| AUC values for medical team compared with/without cELVO | AUC values of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO | Within 2 weeks after completion of reading | 
| Sensitivity and specificity of each reader compared with/without cELVO | Sensitivity and specificity of determining large vessel occlusion of each reader when using cELVO compared to not using cELVO | Within 2 weeks after completion of reading | 
| Sensitivity and specificity of cELVO | Sensitivity and specificity of cELVO in diagnosis of large vessel occlusion based on golden standards | Within 2 weeks after completion of reading |