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A single-center, randomized, crossover and retrospective pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray in screening of abnormalities on chest radiograph

Status Approved

  • First Submitted Date

    2019/07/10

  • Registered Date

    2019/07/16

  • Last Updated Date

    2019/07/27

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004147
    Unique Protocol ID 2018-1251
    Public/Brief Title A single-center, randomized, crossover and retrospective pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray in screening of abnormalities on chest radiograph
    Scientific Title A single-center, randomized, crossover and retrospective pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray in screening of abnormalities on chest radiograph
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2018-1251
    Approval Date 2018-10-14
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sang Min Lee
    Title MD
    Telephone +82-2-3010-4382
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Contact Person for Public Queries
    Name Eunkyung Jung
    Title RA
    Telephone +82-2-515-6646
    Affiliation Vuno
    Address 6F, Gangnam-daero 507, Seocho-gu, Seoul
    Contact Person for Updating Information
    Name Eunkyung Jung
    Title RA
    Telephone +82-2-515-6646
    Affiliation Vuno
    Address 6F, Gangnam-daero 507, Seocho-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-03-14 Actual
    Target Number of Participant 228
    Primary Completion Date 2019-06-07 , Actual
    Study Completion Date 2019-06-07 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-14 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID HI17C2410
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Vuno
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Objective: This study is a single-center, randomized, corossover, and pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray for chest radiography screening.
    Background: Deep learning is a machine learning algorithm that learns on its own the features that reveal the data from a large amount of data. VUNO Inc. builds a deep learning model with a large amount of chest radiographs to automatically detect abnormalities. VUNO Med – Chest X-ray can simplify existing chest radiography screening procedures by analyzing chest radiographs and informing presence of abnormal findings.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Screening
    Phase Not applicable
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    VUNO Med - Chest X-ray software detects abnormalites from uploaded images
    Number of Arms 2
    Arm 1

    Arm Label

    Group 2

    Target Number of Participant

    114

    Arm Type

    Others

    Arm Description

    Phase 1: chest radiograph screening without CAD assistance
    Phase 2 (after washout): chest radiograph screening with CAD assistance
    Arm 2

    Arm Label

    Group 1

    Target Number of Participant

    114

    Arm Type

    Others

    Arm Description

    Phase 1: chest radiograph screening with CAD assistance
    Phase 2 (after washout): chest radiograph screening without CAD assistance
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J98.9)Respiratory disorder, unspecified 

    Chest radiograph screened population
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1) Adults over 19 years old who underwent chest radiography screening from Jan 2016 to Dec 2017
    2) Abnormal lung findings from computed tomography within 1 day of chest radiography screening
    * If one or more of the following is found, it is considered abnormal. However, pneumothorax or effusion may be included even without computed tomography results.
    - 1 ~ 3 cm sized nodule
    - Consolidation
    - Pneumothorax
    - Effusion
    - Interstitial opacity
    Exclusion Criteria
    1) Computed tomography findings cannot be verified in medical records (except pneumothorax or effusion)
    2) A person who is considered difficult to participate in this trial, as determined by the investigators
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    JAFROC (Jackknife Alternative Free-response Receiver Operating Characteristic curve) Figure of merit
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 1
    Outcome
    Sensitivity
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 2
    Outcome
    Specificity
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 3
    Outcome
    False positive
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 4
    Outcome
    Accuracy
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 5
    Outcome
    AUROC (Area Under the Receiver Operating Characteristic curve)
    Timepoint
    After phase 1 and 2 completion
    Secondary Outcome(s) 6
    Outcome
    Reading time
    Timepoint
    After phase 1 and 2 completion
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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