Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028646
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-09-01
Brief Title:
Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None