Airway Clearance System (K031876) Phase IV Device Efficacy

Mack Biotech

Status

Completed

Conditions

Cystic Fibrosis, Pulmonary

Treatments

Device: Electro Flo Percussor, Model 5000

Study type

Observational

Funder types

Industry

Identifiers

NCT03437811

201801MEDSystems

Details and patient eligibility

About

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.

Full description

Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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