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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572619
• Other study ID #: HR-cELVO-01
• Status: Completed
• Start date: March 22, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: Heuron Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• 1st Reading
The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.
• 2nd Reading
The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Namdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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