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

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ClinicalTrials.gov Identifier: NCT04846153
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Nobuhiko Hata, PhD, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Airway Obstruction Other: Human-based Quantification of Airway Stenosis Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Physicians enrolling the study are exclusively assigned to Human-based Quantification.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
Estimated Study Start Date : April 16, 2021
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : July 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arms and Interventions
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Arm Intervention/treatment
Human-based Quantification
No intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously.
 Other: Human-based Quantification of Airway Stenosis
Human-based Quantification of Airway Stenosis From Bronchoscopic Images.
Active Comparator: Computer-based Quantifiction
Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously.
 Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.


Outcome Measures
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Primary Outcome Measures :
  1. Stenosis index quantified [0-100%] [ Time Frame: 1 year ]
    The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846153


Contacts
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Contact: Nobuhiko Hata, PhD 617-732-5809 hata@bwh.harvard.edu
Contact: Artur Banach, MRes abanach@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
More Information
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Responsible Party: Nobuhiko Hata, PhD, Professor of Radiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04846153    
Other Study ID Numbers: AirwayStenosis2021
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, there is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nobuhiko Hata, PhD, Brigham and Women's Hospital:
Airway Stenosis
Stenosis Index Quantification
Additional relevant MeSH terms:
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Airway Obstruction
Constriction, Pathologic
Pathological Conditions, Anatomical
 Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases