Airway Clearance System (K031876) Phase IV Device Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Active Treatment

Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata).

Electro Flo Percussor, Model 5000

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes