RejuvenAir® System Trial for COPD With Chronic Bronchitis
- Conditions
- Chronic Bronchitis
- Interventions
- Device: RejuvenAir SystemDevice: Sham Control Procedure
- Registration Number
- NCT03893370
- Lead Sponsor
- CSA Medical, Inc.
- Brief 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.
- Detailed Description
The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment RejuvenAir System RJA MCS Sham Control Sham Control Procedure Sham
- Primary Outcome Measures
Name Time Method St. George's Respiratory Questionnaire 12 months Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months
- Secondary Outcome Measures
Name Time Method Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure Within 30 days after either the first or second study procedure Number of subjects experiencing one or more serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure by the investigator within 30 days after either the first or second study procedure.
Reduction of cough Baseline through 12 months Reduction of cough from Baseline through 12 months
Acute Exacerbation Rate (AECOPD) 12 months Acute Exacerbation rate (AECOPD, all severities) over 12 months
Reduction of sputum Baseline through 12 months Reduction of sputum from Baseline through 12 months
COPD assessment test (CAT) score 12 months COPD assessment test (CAT) from Baseline through 12 months
Trial Locations
- Locations (27)
Northwestern University
🇺🇸Chicago, Illinois, United States
Johns Hopkins Universtiy
🇺🇸Baltimore, Maryland, United States
Louisiana State University Medical Center
🇺🇸Shreveport, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Temple University - Of the Commonwealth System of Higher Education
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health - Midlands
🇺🇸Columbia, South Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University Of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Advanced Pulmonary Research Institute
🇺🇸Loxahatchee Groves, Florida, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
St. David's Georgetown Hospital
🇺🇸Georgetown, Texas, United States
The Ohio State Universisty
🇺🇸Columbus, Ohio, United States
Clinical Research Associates of Central PA
🇺🇸Altoona, Pennsylvania, United States
Duke University
🇺🇸Durham, North Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
The Royal Brompton Hospital
🇬🇧London, United Kingdom
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States