John C. Lincoln North Mountain Hospital will host a clinical trial that will test airway stents designed to ease emphysema symptoms
Patients with emphysema are being recruited to participate in an international, multicenter clinical trial at John C. Lincoln North Mountain Hospital to explore an investigational, minimally invasive treatment.
North Mountain is the only hospital in Arizona where the EASE (Exhale Airway Stents for Emphysema) clinical trial will be conducted, say researchers at Pulmonary Associates, who are conducting the research.
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Emphysema, a form of COPD (chronic obstructive pulmonary disease), is a disease characterized by chronic, progressive, and irreversible destruction of lung tissue.
The lungs lose their natural elasticity and are unable to exhale effectively, trapping air within the lungs and leading to lung overinflation. Patients have to work very hard just to breathe—making normal activities like walking, eating or even bathing difficult.
There are few treatment options for most patients with severe emphysema and there is no cure.
The trial is testing a catheter- based bronchoscopic procedure designed to reduce lung hyperinflation and shortness of breath (the clinical hallmarks of COPD).
The one- to two-hour procedure creates as many as six new pathways connecting damaged lung tissue to the natural airway, which allows trapped air to exit the lungs. These pathways are supported and kept open by Exhale Drug-Eluting Stents.
The research is a randomized controlled trial, meaning patients will be randomly assigned to either a treatment or a smaller control group. Both groups will undergo bronchoscopy but only the treatment group will receive the airway bypass procedure.
In order to avoid results based on expectations of success, neither the trial participants nor their supervising physicians will know which patients actually had the bypass procedure.
All subjects will have comprehensive medical evaluation and laboratory studies and will receive at least 14 weeks of pulmonary rehabilitation therapy.
Involvement in the study will last from approximately 15 months up to 5 years (depends on whether the patient is randomized to the control or the treatment group) and include 8 to 16 physician appointments.
All study-related medical procedures will be carried out at no charge to the patient and patients will be closely monitored throughout the trial.
"The airway bypass procedure could be an excellent option for those who are not suitable candidates for lung transplant surgery or who would possibly spend years on a lung transplant list," says Bernard Levine, MD, principal investigator of the study at Pulmonary Associates.
"If we can reduce hyperinflation and improve lung function with airway bypass, patients will be able to breathe more easily, leading to a better quality of life."
If someone you know is older than 35, has been diagnosed with advanced widespread emphysema and is no longer smoking (or is willing to stop smoking two months before the study), he or she may qualify to participate in this study.
For more information, contact Pulmonary Associates at 602-258-4951 or visit www.easetrialus.com. |