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Airway Clearance System (K031876) Phase IV Device Efficacy

NCT03437811 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-04-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mack Biotech, Corp.

    lead INDUSTRY

Principal Investigators

  • Leigh J Mack, MD, PhD, CPI · Mack Biotech, Corp.

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-11-01
Completion
2019-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03437811 on ClinicalTrials.gov