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Temple University Hospital Testing Novel Investigational Treatment for Patients with EmphysemA
October 9, 2013
Temple University Hospital is participating in a multi-site, world-wide clinical trial that is testing whether implanting miniature valves in targeted regions of the lung can improve breathing, activity levels and quality of life for patients with emphysema.
"This trial is investigating a novel approach to reducing hyperinflation in the lungs of patients suffering from advanced emphysema," says Gerard J. Criner, MD, Chair of the Department of Medicine at Temple University School of Medicine, and the national co-principal investigator of the trial. "In emphysema cases, decreasing the volume of the targeted damaged area of the lung may potentially result in improved lung function and quality of life."
The trial – called Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema (LIBERATE) – uses a one-way valve that blocks off the targeted diseased lung section to inhaled air but lets the trapped air already inside the area escape. The valve, called the Pulmonx Zephyr®™ Endobronchial Valve (EBV), causes the diseased part of the lung to collapse, allowing the healthier parts of the lung to expand. The EBV is delivered to the patient through a bronchoscope during a short, non-surgical procedure that is performed under conscious sedation or general anesthesia.
"Temple is now one of only four hospitals in the nation taking part in three separate clinical trials testing three different investigational methods of lung volume reduction," adds Dr. Criner, who is also Director of the nationally-ranked Temple Lung Center, one of the nation's leaders in the diagnosis, treatment and research of patients with complex lung problems. "This trial, along with ongoing trials investigating the effectiveness of miniature coils and a synthetic, injectable foam sealant in the reduction of hyperinflation, serve to give our patients access to an even wider variety of innovative clinical research opportunities."
The LIBERATE study is a randomized controlled study. After a pre-screening process, those who meet the clinical criteria for study participation are randomized to either standard-of-care (the control group) or undergo the valve insertion procedure. Patients stay in the hospital for a minimum of two nights after the procedure and then go through up to one year of follow up doctor's visits and tests.
The results of patients who received the EBV will be compared to those that receive standard medical therapy alone. The measure of success for the trial will be whether the patients who receive the EBV have a greater degree of lung function improvement than patients who do not have the valve.
Temple is currently screening patients for the LIBERATE trial, and expects to enroll its first patient in the next few weeks. Interested patients may contact Kathy McLeer, RN, research program manager, at 215-707-4821 for more information.
Editor's Note: This trial is sponsored by Pulmonx, the manufacturer of the EBV device. Dr. Criner has no financial interest in Pulmonx.
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