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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03704207
Other study ID # IRB #160951
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 1, 2025

Study information

Verified date December 2023
Source Vanderbilt University Medical Center
Contact Michael O'Connor, MD
Phone 615.343.7617
Email michael.g.oconnor@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.


Description:

This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria: - Referred to center for PCD diagnosis considerations - Ability to perform study procedures - Age greater than 2 years of age Exclusion Criteria: - Age less than 2 years of age Inability to perform informed consent

Study Design


Intervention

Other:
nNO testing
Collection of already performed clinical data and nNO testing

Locations

Country Name City State
United States Vanderbilt Children's hospital Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of nNO tests performed number of tests 3 years
Primary Frequency of genetic tests performed number of tests 3 years
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