June 10, 2007 Researchers at Cedars-Sinai Medical Center announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a new, minimally-invasive option for those suffering with advanced widespread emphysema. The study focuses on an experimental procedure called airway bypass designed to create pathways in the lung for trapped air to escape with the goal of relieving shortness of breath and other emphysema symptoms.
Emphysema is a chronic, progressive, and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lungs' natural elasticity and the collapse of airways in the lung combine to make exhalation ineffective, leaving the emphysema sufferer with hyperinflation because they can't get air out of their lungs. With hyperinflation, breathing becomes inefficient and the patient is always short of breath. Even the most nominal physical activities become difficult for emphysema patients and many become dependent on oxygen therapy.
"We are excited to be part of this study because currently there are limited treatment options for the emphysema patients," said Zab Mosenifar, M.D., Medical Director of Cedars-Sinai Center for Chest Diseases and principal investigator of the study at Cedars-Sinai. "Patients are often in poor physical condition, struggling with each breath. By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and improve lung function. If patients can breathe easier it is likely to improve their quality of life."
During airway bypass, physicians will use a flexible bronchoscope to go through the mouth into the airways. There the physician will create new small pathways and place an Exhale® Drug-Eluting Stent -- manufactured by Broncus Technologies, Inc. - to allow the trapped air in the lung to escape.
"The airway bypass procedure could be a good option for those who would possibly spend years on a lung transplant list or not be suitable candidates for lung transplant surgery, which is one of the only other treatment options available for patients with this type of emphysema," said Mosenifar.
Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is away from blood vessels. A special needle is then used to make a small opening and an Exhale® Drug-Eluting Stent is placed in the passageway to keep it open. The procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately one to two hours.
This procedure is still under clinical investigation, but early data suggest it may be beneficial to patients with emphysema.
Emphysema affects an estimated 60 million people worldwide with more than 3 million sufferers in the United States. There is no cure for emphysema.
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