Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Oct 20, 2026
    • Trial completed
    • Final enrollment: 14 participants (planned 25)
    • Primary completion date changed from estimate of Jun 30, 2025 to Jun 17, 2024
    • Secondary endpoints revised (7)
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 5 words
  2. Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025v3
  3. Primary and study completion dates: Oct 10, 2023 to Jun 30, 2024v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06028646
Lead Sponsor NYU Langone Health
Conditions
(from sponsor)		 Tracheomalacia
Related terms Tracheomalacia
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov