Airway Clearance System (K031876) Phase IV Device Efficacy

Cystic Fibrosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437811
• Other study ID #: 201801MEDSystems
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: April 2020
• Source: Mack Biotech, Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis, Pulmonary
• Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	MED Systems, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Mack Biotech, Corp.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002011. Review. — View Citation

Oermann CM, Sockrider MM, Giles D, Sontag MK, Accurso FJ, Castile RG. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001 Nov;32(5):372-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of oxygen levels in the blood (pulse oximetry).	SpO2 will be monitored using the standard pulse oximeter system (K131111).	Change from baseline up to 3.5 hours.
Secondary	Percentage change of lung function	Evaluate expiratory forced vital capacity (FVC) and forced expiratory volume (FEV1) will be monitored with standard spirometer.	Change from baseline up to 3.5 hours

External Links

•   Cleared device information