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

April 14, 2021 updated by: Nobuhiko Hata, PhD, Brigham and Women's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 16, 2021

Primary Completion (Anticipated)

April 16, 2021

Study Completion (Anticipated)

July 16, 2021

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AirwayStenosis2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently, there is no plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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