Skip to main content
OpenTrials
Completed

NCT Number: NCT05572619

Evaluation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1st Reading

Device

The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.

Other names: Stage 1

2nd Reading

Device

The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.

Other names: Stage 2

Primary outcomes

  1. Sensitivity and specificity of medical team compared with/without cELVO

    Time frame: 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 outcomes

  1. Accuracy of medical team compared with/without cELVO

    Time frame: Within 2 weeks after completion of reading

    Accuracy of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO

  2. ROC Curve for medical team compared with/without cELVO

    Time frame: 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

  3. AUC values for medical team compared with/without cELVO

    Time frame: 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

  4. Sensitivity and specificity of each reader compared with/without cELVO

    Time frame: 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

  5. Sensitivity and specificity of cELVO

    Time frame: Within 2 weeks after completion of reading

    Sensitivity and specificity of cELVO in diagnosis of large vessel occlusion based on golden standards

Sponsors and collaborators

Lead sponsor

Heuron Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.