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
About this trial
This is an interventional other trial for Airway Obstruction focused on measuring Airway Stenosis, Stenosis Index Quantification
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
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
NCT ID
NCT04846153
First Posted
April 12, 2021
Last Updated
April 14, 2021
Sponsor
Brigham and Women's Hospital
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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