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Respiratory Assist Device

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

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
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess distance travelled during 6-minute walk tests performed with and without device.
Secondary study objectives
Assess for patient improvement in shortness of breath scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
2,083 Previous Clinical Trials
42,726,742 Total Patients Enrolled
Right-AirLead Sponsor
John Hansen-Flaschen, MDPrincipal InvestigatorUniversity of Pennsylvania
~4 spots leftby Dec 2025
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