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Respiratory Assist Device
Part 2: Crossover for Chronic Obstructive Pulmonary Disease
N/A
Waitlist Available
Led By John Hansen-Flaschen, MD
Research Sponsored by Right-Air
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
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.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess distance travelled during 6-minute walk tests performed with and without device.
Secondary outcome measures
Assess for patient improvement in shortness of breath scores
Trial Design
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.
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Who is running the clinical trial?
University of PennsylvaniaOTHER
2,004 Previous Clinical Trials
42,882,119 Total Patients Enrolled
Right-AirLead Sponsor
John Hansen-Flaschen, MDPrincipal InvestigatorUniversity of Pennsylvania
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