Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

NCT ID: NCT06028646

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Tracheomalacia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dynamic Airway CT scan (DA-CT)

All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

Group Type EXPERIMENTAL

Dynamic Airway CT scan (DA-CT)

Intervention Type DEVICE

Patient will be asked to perform movements during the scan.

Interventions

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Dynamic Airway CT scan (DA-CT)

Patient will be asked to perform movements during the scan.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eleanor Muise, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Fink Children's Ambulatory Center/Hassenfeld Children's Center

New York, New York, United States

Site Status RECRUITING

Tisch Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Soumia Hammouda

Role: CONTACT

347-204-3293

Other Identifiers

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22-01279

Identifier Type: -

Identifier Source: org_study_id

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