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

Sponsor
Heuron Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05572619
Collaborator
(none)
479
Enrollment
1
Location
5.6
Actual Duration (Months)
85.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 1st Reading
  • Device: 2nd Reading

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
479 participants
Observational Model:
Case-Crossover
Time Perspective:
Other
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
Actual Study Start Date :
Mar 22, 2022
Actual Primary Completion Date :
Sep 8, 2022
Actual Study Completion Date :
Sep 8, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gachon University Gil Medical Center Incheon Namdong-gu Korea, Republic of 21565

    Sponsors and Collaborators

    • Heuron Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heuron Inc.
    ClinicalTrials.gov Identifier:
    NCT05572619
    Other Study ID Numbers:
    • HR-cELVO-01
    First Posted:
    Oct 7, 2022
    Last Update Posted:
    Oct 7, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ischemic Stroke

    Study Results

    No Results Posted as of Oct 7, 2022