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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04846153
Other study ID # AirwayStenosis2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 16, 2021
Est. completion date July 16, 2021

Study information

Verified date April 2021
Source Brigham and Women's Hospital
Contact Nobuhiko Hata, PhD
Phone 617-732-5809
Email hata@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3
Est. completion date July 16, 2021
Est. primary completion date April 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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