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NCT03437811

Airway Clearance System (K031876) Phase IV Device Efficacy

Completed Last updated 10 April 2020
What this trial tests

trial testing Electro Flo Percussor, Model 5000 in Cystic Fibrosis, Pulmonary in 16 participants. Completed in 1 November 2019.

Timeline
28 February 2018
Primary endpoint
1 November 2019
1 November 2019

Quick facts

Lead sponsorMack Biotech, Corp.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment16
Start date28 February 2018
Primary completion1 November 2019
Estimated completion1 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mack Biotech, Corp.

Who can join

Adults 18 to 55, any sex, with Cystic Fibrosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cystic Fibrosis, Pulmonary

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03437811.

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