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

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: 1st Reading; Device: 2nd Reading

• Registration Number: NCT05572619
• Lead Sponsor: Heuron Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive group	1st Reading	A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
Negative group	2nd Reading	A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography
Positive group	2nd Reading	A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
Negative group	1st Reading	A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Namdong-gu, Korea, Republic of