common.study.topics.clinical

Airway Clearance Therapy for Cystic Fibrosis

common.study.values.description

Airway Clearance System (K031876) Phase IV Device Efficacy

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 30 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Device - Electro Flo Percussor, Model 5000

FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1

participant.views.study.view.additional

participant.views.study.view.scientific-title

Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.

common.study.values.clinical-trial-id

NCT03437811

participant.views.study.view.id

DbDm5d