Med Systems is sponsoring a Phase IV clinical study to measure the effectiveness of the Electro Flo 5000 Airway Clearance System for people who have been diagnosed with cystic fibrosis. The goal of the study is to provide health insurers and Medicare with comprehensive information regarding the system’s performance. The study is designed to measure the efficacy of the system, which includes the FDA510K (K031876) device under current indications. The study will last 23 days and involve using the system for lung clearance and recording the results in a digital journal. The study should take about 10 minutes per day to record measured results in the morning after waking. You will also be asked to use a spirometer and a digital pulse oximeter to evaluate your lung function after using the Electro Flo 5000 Airway Clearance System. Participants will be offered reimbursement amount of $7.00 a day, for submitted daily data, for a total of 21 days.
Interested participants must be:
- Between the ages of 18-55 years of age
- Diagnosed with Cystic Fibrosis
- Prescribed chest physical therapy for airway clearance
- Able to perform self-treatment- having manual dexterity
- Residing in the United States