BARRX Medical, Inc. has announced that 98.4 percent of patients having a precancerous condition of their esophagus called Barrett's esophagus were free of the disease 2.5 years after non-surgical, endoscopic treatment with the HALO ablation system.
The results were published this month in Gastrointestinal Endoscopy, a leading scientific publication for gastrointestinal physicians and researchers. Barrett's esophagus develops as a result of chronic gastroesophageal reflux disease (GERD) and afflicts more than 3.3 million people in the United States.
In this clinical trial, eight U.S. centers enrolled 70 patients having intestinal metaplasia, which is the earliest stage of Barrett's esophagus. Due to an elevated risk for developing esophageal cancer, patients with this disorder undergo a lifetime of endoscopic examinations to detect progression to more severe stages of the disease or cancer. Patients in this trial received one or more endoscopic treatments using two components of the HALO ablation system -- the HALO360 and HALO90 ablation catheters -- to remove the diseased cells of the esophagus. The HALO360 intervention treats large, circumferential areas of the esophagus. The HALO90 intervention targets focal, non-circumferential disease.
After treatment, patients in this trial were monitored for 2.5 years and had regular endoscopic examinations to confirm if all the diseased areas were eliminated. At the final evaluation at 2.5 years, 98.4 percent of the patients had achieved a complete response to therapy and had no remaining disease. The researchers also reported a favorable safety profile of the therapy with no serious negative side effects occurring such as narrowing of the esophagus (i.e. strictures) or hidden disease under the healed surface of the esophagus (i.e. buried glands).
David E. Fleischer M.D., Professor of Medicine, Mayo College of Medicine, and staff physician in the Department of Gastroenterology at Mayo Clinic in Scottsdale, Ariz., was lead author on the published paper. Fleischer believes the study is an important step in understanding the best way to manage patients with Barrett's esophagus at the earliest phase of this disease and reports there are several on-going trials that continue adding to our knowledge of this technique.
"The findings of this prospective trial are an important advance for gastrointestinal medicine since this therapy allows us to safely and completely remove the abnormal Barrett's tissue from a patient's esophagus using a endoscopic technique," said principle investigator Charles J. Lightdale, M.D., Professor of Clinical Medicine, Columbia University Medical Center in New York. "We may learn that taking a proactive approach to eliminate the Barrett's disease may provide a significant benefit in the form of reducing risk for disease progression, patient anxiety, healthcare costs, and need for life-long surveillance."
"During this year's Digestive Disease Week 2008, there were 17 scientific presentations related to HALO ablation for Barrett's esophagus, including the interim analysis for a rigorous, randomized, sham controlled trial which demonstrated a reduction in disease progression and cancer incidence associated with this therapy," said David S. Utley, M.D., Chief Medical Officer, BARRX Medical, Inc. "This growing body of scientific evidence, combined with the completion of more than 18,000 procedures worldwide, is an important step towards our goal of reducing the incidence of esophageal cancer."