Status:
COMPLETED
Airway Clearance System (K031876) Phase IV Device Efficacy
Lead Sponsor:
Mack Biotech, Corp.
Conditions:
Cystic Fibrosis, Pulmonary
Eligibility:
All Genders
18-55 years
Brief Summary
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 t...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03437811
Start Date
February 28 2018
End Date
November 1 2019
Last Update
April 10 2020
Active Locations (1)
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1
MED Systems, Inc.
San Diego, California, United States, 92117