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Airway Clearance System (K031876) Phase IV Device Efficacy

Mack Biotech, Corp. · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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cystic-fibrosispulmonary
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.
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