Airway Clearance System (K031876) Phase IV Device Efficacy

Completed

• Conditions: Cystic Fibrosis, Pulmonary
• Interventions: Device: Electro Flo Percussor, Model 5000

• Registration Number: NCT03437811
• Lead Sponsor: Mack Biotech, Corp.

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 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.

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 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.

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2018-02-28
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Treatment	Electro Flo Percussor, Model 5000	Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata).

Primary Outcome Measures

Name	Time	Method
Percentage change of oxygen levels in the blood (pulse oximetry).	Change from baseline up to 3.5 hours.	SpO2 will be monitored using the standard pulse oximeter system (K131111).

Secondary Outcome Measures

Name	Time	Method
Percentage change of lung function	Change from baseline up to 3.5 hours	Evaluate expiratory forced vital capacity (FVC) and forced expiratory volume (FEV1) will be monitored with standard spirometer.

Trial Locations

Locations (1)

MED Systems, Inc.; 🇺🇸 San Diego, California, United States