Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
Recruiting in Palo Alto (17 mi)
Overseen byJohn Hansen-Flaschen, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Right-Air
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
1. Moderate to severe COPD (by ATS criteria)
FEV1/FVC <0.70
FEV1 < 60% Predicted
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2: CrossoverExperimental Treatment1 Intervention
Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.
Group II: Part 1: FeasibilityExperimental Treatment1 Intervention
Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
John Hansen-FlaschenPhiladelphia, PA
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Who Is Running the Clinical Trial?
Right-AirLead Sponsor
University of PennsylvaniaCollaborator