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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: 1st Reading; Device: 2nd Reading

• Study Type: Observational
• Enrollment (Actual): 479

Contacts and Locations

Study Locations

• Korea, Republic of
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Gachon University Gil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

(1) Adults over 19 years old (2) Brain non-contrast CT, CT perfusion and CT angiography acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heuron Inc.
• Investigators: Principal Investigator: Myeong Jin Kim, M.D.pH.D, Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: HR-cELVO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No