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Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images

Primary Purpose

Airway Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Human-based Quantification of Airway Stenosis
Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Airway Obstruction focused on measuring Airway Stenosis, Stenosis Index Quantification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physicians who are trained in bronchoscopy.
  • Physicians who are willing and able to understand the scope of the study.

Exclusion Criteria:

  • Physicians who are not trained in bronchoscopy.
  • Physicians who are unwilling and unable to understand the study procedure
  • Employees under the direct supervision of the investigators conducting the research

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Human-based Quantification

    Computer-based Quantifiction

    Arm Description

    No intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously.

    Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously.

    Outcomes

    Primary Outcome Measures

    Stenosis index quantified [0-100%]
    The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2021
    Last Updated
    April 14, 2021
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04846153
    Brief Title
    Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
    Official Title
    Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 16, 2021 (Anticipated)
    Primary Completion Date
    April 16, 2021 (Anticipated)
    Study Completion Date
    July 16, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Airway Obstruction
    Keywords
    Airway Stenosis, Stenosis Index Quantification

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Physicians enrolling the study are exclusively assigned to Human-based Quantification.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    3 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Human-based Quantification
    Arm Type
    Other
    Arm Description
    No intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously.
    Arm Title
    Computer-based Quantifiction
    Arm Type
    Active Comparator
    Arm Description
    Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously.
    Intervention Type
    Other
    Intervention Name(s)
    Human-based Quantification of Airway Stenosis
    Intervention Description
    Human-based Quantification of Airway Stenosis From Bronchoscopic Images.
    Intervention Type
    Device
    Intervention Name(s)
    Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
    Intervention Description
    Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
    Primary Outcome Measure Information:
    Title
    Stenosis index quantified [0-100%]
    Description
    The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Physicians who are trained in bronchoscopy. Physicians who are willing and able to understand the scope of the study. Exclusion Criteria: Physicians who are not trained in bronchoscopy. Physicians who are unwilling and unable to understand the study procedure Employees under the direct supervision of the investigators conducting the research
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nobuhiko Hata, PhD
    Phone
    617-732-5809
    Email
    hata@bwh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Artur Banach, MRes
    Email
    abanach@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Currently, there is no plan to share IPD.

    Learn more about this trial

    Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images

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