Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
NCT03531489 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-05-21
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.
Conditions
Interventions
- DEVICE
-
AIR-AD
Non-significant risk medical device as decided by institutional review board
Sponsors & Collaborators
- collaborator OTHER
-
Right-Air
lead INDUSTRY
Principal Investigators
-
John Hansen-Flaschen, MD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-26
- Primary Completion
- 2018-12-30
- Completion
- 2018-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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