Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03893370
NA

RejuvenAir® System Trial for COPD With Chronic Bronchitis

Sponsor: CSA Medical, Inc.

View on ClinicalTrials.gov

Summary

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

Official title: A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2020-07-09

Completion Date

2026-09

Last Updated

2024-06-03

Healthy Volunteers

No

Interventions

DEVICE

RejuvenAir System

RejuvenAir Metered CryoSpray

DEVICE

Sham Control Procedure

Sham Control Procedure

Locations (27)

Honor Health

Scottsdale, Arizona, United States

El Camino Hospital

Mountain View, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Northwestern University

Chicago, Illinois, United States

Louisiana State University Medical Center

Shreveport, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Universtiy

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper Health System

Camden, New Jersey, United States

Duke University

Durham, North Carolina, United States

University Of Cincinnati

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State Universisty

Columbus, Ohio, United States

Clinical Research Associates of Central PA

Altoona, Pennsylvania, United States

Temple University - Of the Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health - Midlands

Columbia, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

St. David's Georgetown Hospital

Georgetown, Texas, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

The Royal Brompton Hospital

London, United Kingdom