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 (SPRAY-CB)
Study Type/Phase: Interventional
Enrollment Status: Recruiting
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem with an unmet medical need. Chronic Bronchitis (CB) is defined as chronic cough and sputum production for 3 months a year for 2 consecutive years. CB is associated with many consequences, including; the worsening of lung function, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, and reduced health-related quality of life.
The RejuvenAir System is a new device developed as a treatment option for CB. This study uses the RejuvenAir™ System, which delivers liquid nitrogen through a catheter to instantly flash freeze the lining of the airways (also called metered spray cryotherapy). Liquid Nitrogen has been used for over 50 years to treat other medical conditions that require regeneration of unhealthy tissue, such as when a doctor sprays a patient's skin with liquid nitrogen to get rid of unhealthy tissue. However, the use of liquid nitrogen in this study, to treat symptomatic chronic bronchitis, is a new use of this freezing agent.
This is a randomized study to evaluate the safety and effectiveness of the RejuvenAir System developed for patients with chronic bronchitis. This device has not been approved by the U.S. Food and Drug Administration (FDA).
330 subjects will take part in this study at 30 sites in the United States, Canada, and Europe. Approximately 20 subjects will take part in this study at Mountain View Hospital (El Camino Hospital).
Speak with your doctor to determine whether you meet the following criteria for participation in this study.
|Inclusion Criteria||Exclusion Criteria|
For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.