Physicians at Cooper University Health Care are taking part in a clinical trial to test the effectiveness of a less invasive treatment for patients with severe emphysema. Cooper is one of about 24 sites participating in the EMPROVE clinical trial in the United States.
Wissam Abouzgheib, MD, Director, Section of Interventional Pulmonology, Division of Pulmonary Medicine, is leading Cooper’s participation in the EMPROVE trial. The trial will specifically evaluate the safety and efficacy of endobronchial valves – small implantable medical devices – for patients with severe emphysema. Currently, these patients have limited therapeutic options or being evaluated for lung transplant or volume reduction surgery, which removes part of the poorly functioning areas of the lung.
“Emphysema is a disease of the lungs that can make breathing difficult,” explained Dr. Abouzgheib. “Lungs are made up of tiny air sacs that absorb the oxygen in the air we breathe. In patients with emphysema, these air sacs are gradually destroyed, which makes it difficult for air to exit the sacs and allows it to become trapped in the most diseased areas of the lung.” The trapped air is what makes “breathing difficult” and also interferes with the function of the healthier areas of the lung
COPD and Emphysema are serious medical conditions that affect millions and are directly linked to smoking. According to the American Lung Association, COPD/Emphysema is the third leading cause of death in America, claiming the lives of 134,676 Americans in 2010.
About the Trial
Through the EMPROVE trial a valve is placed inside the airways of diseased or hyperinflated parts of the lung and redirects the air to healthier parts of the lung, making it easier for the patient to breathe.
The trial is composed of two randomly chosen groups. The treatment group will have valves placed in the lung and be monitored by a doctor. The control group will not have valves placed in the lung, but will also receive care from a trial doctor for the length of the trial. Using this random control method means that the groups will be similar and that the treatments the patients receive can be compared objectively to determine which treatment is best. The randomization is two patients for the valve group to one patient to the control group, increasing the chances to be chosen to receive the valves
Before a patient can enter the EMPROVE trial, a doctor will review their medical history to determine if they are an appropriate candidate. Not all COPD or emphysema patients will benefit from the procedure and there are some significant risks. Potential benefits and risks will be reviewed with all eligible patients by the trial doctor and a member of the trial support team.
Following the procedure, participants will monitored at one month, three months and six months. In addition, patients in the treatment group will receive annual check-ups for five years, while patients in the control group will receive annual check-ups for two years.
If you are a patient suffering from emphysema and would like to know more about the EMPROVE Clinical Trial, please contact Patricia Niblack 856.968.7269.