NCT03437811|CompletedFDA Device
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.
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Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.
Sponsor study identifier
observational
16
1 country
1
Study Start
February 28, 2018
Actual (reported)Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2018
Actual (reported)February 19, 2018
Actual (reported)February 28, 2018
Actual (reported)November 1, 2019
Actual (reported)November 1, 2019
Actual (reported)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.
Percentage change of lung function
Change from baseline up to 3.5 hours
Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata).
FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
18 to 55 years of age, male or female.non-smokers
MED Systems, Inc.
San Diego, California, 92117, United States
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.
Leigh J Mack, MD, PhD, CPI
Mack Biotech, Corp.
16 participants (actual enrollment reported by the registry).
First Submitted
January 17, 2018
First Posted
February 19, 2018
Study Start
February 28, 2018
Actual (reported)Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)Last Updated
April 10, 2020
Record last verified: 2020-04
Available final outcomes for complete study shall be available December 31, 2019. No individual specific outcomes shall be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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