Airway Clearance System (K031876) Phase IV Device Efficacy

NCT03437811 | Completed FDA Device

• 1 other identifier: 201801MEDSystems
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis, Pulmonary

Keywords

airway clearance system; cystic fibrosis; lung secretion clearance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage change of lung function

  Change from baseline up to 3.5 hours

Study Arms (1)

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

Interventions

Electro Flo Percussor, Model 5000 DEVICE

FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1

Active Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mack Biotech, Corp.: lead

Study Sites (1)

MED Systems, Inc.

San Diego, California, 92117, United States

Location

Related 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;2005(1):CD002011. doi: 10.1002/14651858.CD002011.pub2.

  PMID: 15674888 BACKGROUND

• 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.

  PMID: 11596162 BACKGROUND

Related Links

• Cleared device information

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Leigh J Mack, MD, PhD, CPI

  Mack Biotech, Corp.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (CEO)

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 19, 2018
• Study Start: February 28, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)