Airway Clearance System (K031876) Phase IV Device Efficacy

Sponsor

Mack Biotech, Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT03437811

Collaborator

(none)

Enrollment

Location

20.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis, Pulmonary	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 Design

Study Type:

Observational

Actual Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 28, 2018

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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