Airway Clearance System (K031876) Phase IV Device Efficacy

Completed

Conditions studied: Cystic Fibrosis, Pulmonary

In brief

Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.

Key facts

Study ID

NCT03437811

Run by

Mack Biotech, Corp.

People needed

16

Starts

2018-02-28

Expected to finish

2019-11-01

Last updated by the study team

2020-04-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Previously diagnosed with cystic fibrosis (mild, moderate or severe)
• Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance
• Physically able to perform self-treatment or treatment by an at home medical provider

You may not qualify if…

• History of tobacco use
• History of excessive alcohol consumption, more than 2 drinks per day, 10 per week
• Any other medical condition that would preclude use of an airway clearance device
• Previously diagnosed with major cardiological disease

Where it is running

• MED Systems, Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

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