Sacramento, Calif – UC Davis Medical Center is among several sites across the United States that is now recruiting patients with acute and chronic conditions of the lung for a study of a minimally invasive treatment for severe emphysema.
The study is open to men and women age 40 to 74 who have been diagnosed with predominantly upper lobe emphysema and shortness of breath with exertion. Eligible patients must be able to participate in pulmonary function and standardized exercise tests, have not smoked for four months, and be willing to not smoke during the trial. Additional criteria must be met for participation in the study.
The study will assess the IBV Valve System, a minimally invasive treatment that has diverse applications in both acute and chronic conditions of the lung. During the minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the bronchial tubes through the mouth or nose) to deploy the small umbrella-shaped valves into the airways of the lungs. The valves are designed to be easily removed via a similar bronchoscopic procedure.
The study will generate safety and effectiveness data for submission to the U.S. Food and Drug Administration (FDA). This prospective, randomized, blinded clinical trial will enroll up to 500 patients at up to 50 sites in the United States.
The device has received Humanitarian Device Exemption (HDE) approval from the FDA to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged, following lobectomy, segmentectomy, or lung volume reduction surgery. The effectiveness of this device for this use has not been demonstrated.
The IBV Valve System is currently under investigation in the U.S. as a new treatment option for the many people with severe emphysema who do not respond well to current medical therapies or are not eligible for or elect not to undergo invasive surgery such as lung volume reduction or lung transplantation.