Airway Clearance System (K031876) Phase IV Device Efficacy

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis, Pulmonary
• Intervention / Treatment: Device: Electro Flo Percussor, Model 5000

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92117
      • MED Systems, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18 to 55 years of age, male or female.non-smokers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mack Biotech, Corp.
• Investigators: Principal Investigator: Leigh J Mack, MD, PhD, CPI, Mack Biotech, Corp.

Publications and helpful links

General Publications

• 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;2005(1):CD002011. doi: 10.1002/14651858.CD002011.pub2.
• 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. doi: 10.1002/ppul.1146.

Helpful Links

• Cleared device information

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: cystic fibrosis; airway clearance system; lung secretion clearance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 201801MEDSystems

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available final outcomes for complete study shall be available December 31, 2019. No individual specific outcomes shall be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes