Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06028646
Status
Recruiting
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Conditions

  • Tracheomalacia

Eligibility Criteria

Sex
ALL
Age
0 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dynamic Airway CT scan (DA-CT) — DEVICE
    Patient will be asked to perform movements during the scan.

Study Details

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.

Key Dates

Start date
Aug 10, 2023
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Dynamic Airway CT scan (DA-CT)
    All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

Primary Outcome Measure

Severity of dynamic narrowing on Flexible Bronchoscopy [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fink Children's Ambulatory Center/Hassenfeld Children's CenterNew YorkNew York10016-
Tisch HospitalNew YorkNew York10016-

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By research site
Fink Children's Ambulatory Center/Hassenfeld Children's Center· New York, NYTisch Hospital· New York, NY