Temple University Hospital has joined a pivotal clinical trial testing an investigational medical device developed for patients with chronic obstructive pulmonary disease (COPD). The Hemolung Respiratory Assist System (RAS), developed by ALung Technologies, Inc., is a dialysis-like device that uses extracorporeal carbon dioxide removal (ECCO₂R) to treat patients with acute COPD exacerbations that require respiratory support. The VENT-AVOID Trial will evaluate the safety and efficacy of the device in providing ECCO₂R as an alternative or supplement to invasive mechanical ventilation for these patients. The trial is sponsored by ALung Technologies, and is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration.
“Temple recently enrolled its first patient in the VENT-AVOID Trial and we’re pleased to be participating,” said Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center. “Extracorporeal carbon dioxide removal is promising and we’re hopeful that it could ultimately provide a safe and less invasive alternative to intubation and mechanical ventilation for some COPD patients.”
According to the American Lung Association, more than 11 million people in the U.S. suffer from COPD and it is the third leading cause of death. Patients with COPD are prone to exacerbations where their symptoms suddenly become worse. These exacerbations can lead to high levels of carbon dioxide building up in the patient, which can result in respiratory failure and the need for life-saving intubation and mechanical ventilation.
VENT-AVOID is a prospective, multi-center, randomized, controlled, two-arm, pivotal trial. Eligible patients will be randomized to one of two treatment arms.
Patients in the first treatment arm will receive lung support with the Hemolung RAS plus standard-of-care mechanical ventilation. Hemolung RAS consists of a catheter that is inserted into the femoral or jugular vein. The patient’s blood travels through tubing to the Hemolung cartridge where carbon dioxide is removed independent of the lungs. The blood is then pumped back to the patient.
Patients in the second treatment arm will receive standard-of-care mechanical ventilation alone. The primary outcome measure for the trial is the number of ventilator-free days measured from the time the patient is randomized to a treatment arm through 60 days post-randomization. Temple is one of only 31 sites in the U.S. currently participating in the trial.
The Temple Lung Center has one of the most active and wide-ranging pulmonary research programs in the world. Areas of focus include COPD, emphysema, respiratory failure, lung transplantation, pulmonary arterial hypertension, alpha 1-antitrypsin deficiency, asthma, lung cancer, sarcoidosis, pulmonary fibrosis and sleep apnea.