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

NCT04846153 | Unknown DMC

• 1 other identifier: AirwayStenosis2021
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Obstruction

Keywords

Airway Stenosis; Stenosis Index Quantification

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Human-based Quantification

OTHER

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

Computer-based Quantifiction

ACTIVE COMPARATOR

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

Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.

Interventions

Human-based Quantification of Airway Stenosis OTHER

Human-based Quantification of Airway Stenosis From Bronchoscopic Images.

Human-based Quantification

Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. DEVICE

Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.

Computer-based Quantifiction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Nobuhiko Hata, PhD

CONTACT

617-732-5809; hata@bwh.harvard.edu

Artur Banach, MRes

CONTACT

abanach@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Model Details: Physicians enrolling the study are exclusively assigned to Human-based Quantification.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: April 16, 2021
• Primary Completion: April 16, 2021
• Study Completion: July 16, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share