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Purpose

The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.

Condition

Eligibility

Eligible Ages
Between 0 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants 0-18 years old, with - Clinically indicated flexible bronchoscopy has been performed

Exclusion Criteria

  • Pregnancy or breastfeeding - Unable to undergo CT scanning without sedation - Patients with tracheostomy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dynamic Airway CT scan (DA-CT) 		All participants will have a DA-CT scan after flexible bronchoscopy has been performed.
  • Device: Dynamic Airway CT scan (DA-CT)
    Patient will be asked to perform movements during the scan.

Recruiting Locations

Fink Children's Ambulatory Center/Hassenfeld Children's Center
New York, New York 10016

Tisch Hospital
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Soumia Hammouda
347-204-3293
Soumia.Hammouda@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.