NCT06028646

Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tracheomalacia

Interventions

Type	Name	Description
DEVICE	Dynamic Airway CT scan (DA-CT)	Patient will be asked to perform movements during the scan.

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-09-08
• Last updated: 2024-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study