Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

Status unconfirmed · Not applicable

Conditions studied: COPD, Chronic Obstructive Pulmonary Disease

In brief

The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.

Key facts

Study ID

NCT03531489

Run by

Right-Air

People needed

30

Starts

2018-04-26

Expected to finish

2018-12-30

Last updated by the study team

2018-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe COPD (by ATS criteria)
• FEV1/FVC <0.70
• FEV1 < 60% Predicted

You may not qualify if…

• Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…)
• Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…)
• Pregnancy
• Age <18

Where it is running

• John Hansen-Flaschen — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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