Recruiting

Ambulatory Respiratory Assist Device

Sponsor:

Right-Air

Code:

NCT03531489

Conditions

COPD

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AIR-AD

Study Details

Brief 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

COPD

Chronic Obstructive Pulmonary Disease

Study ID

NCT03531489

Start date

Apr 26, 2018

Status verified date

May, 2018

Completion date

Dec 30, 2018

Anticipated

Primary completion date

Dec 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Moderate to severe COPD (by ATS criteria)

1. FEV1/FVC <0.70
2. FEV1 < 60% Predicted

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Feasibility

Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.

experimental: Part 2: Crossover

Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.

Interventions

AIR-AD

Non-significant risk medical device as decided by institutional review board

Primary outcome measure

  • Assess distance travelled during 6-minute walk tests performed with and without device. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Maria Escobar

215-349-5023escobarm@pennmedicine.upenn.edu

Perry Dubin, MD/MPH

6105172053

Locations

John Hansen-Flaschen

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Maria Escobar

215-349-5023escobarm@pennmedicine.upenn.edu

More Information

Sponsor

Right-Air

Last update posted

May 21, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Right-Air on 2018-05-21.