SUNNYVALE, California, June 1 /PRNewswire/ --
- Large multi-center trial conducted in a community practice setting demonstrates comparable outcomes as trials conducted in predominantly tertiary academic centers
Clinical trial results presented at the Digestive Disease Week in Chicago today reveal that endoscopic radiofrequency ablation performed in a community practice setting is safe and effective for eradicating a pre-cancerous esophageal condition known as Barrett's esophagus. The study is entitled, Radiofrequency Ablation of Barrett Esophagus: Outcomes of 429 Patients from a Multi-center Community Practice Registry and was presented today by Ronald E. Pruitt, M.D., Nashville, TN, at a scientific session sponsored by the American Society of Gastrointestinal Endoscopy.
The study's author reported on 429 patients with Barrett's esophagus, with and without advanced dysplasia (cellular signs of advanced progression towards cancer), who were treated with radiofrequency ablation using the HALO ablation system (BARRX Medical, Sunnyvale, CA) over the last 4 years. They report that the adverse event rate was favorable, with a low stricture risk (about 1%) and no serious adverse events. After an average of 2 ablation procedures and 20 month follow-up, 77% of patients were cured of their Barrett's disease. For those patients that had baseline evidence of dysplasia, 100% had complete eradication of all signs of dysplasia.
We believe that the results of our trial are unique and relevant to the scientific knowledge-base, as this is the largest patient experience reported to date and the first multi-center trial conducted at community practice centers for using radiofrequency ablation to eradicate Barrett's esophagus, said Dr. Pruitt. Most importantly, we found that the safety and efficacy outcomes garnered in this clinical setting comport with those from reported trials conducted as predominantly academic tertiary referral centers.
Study centers were comprised of large community practices with expertise in therapeutic endoscopy and the management of Barrett's esophagus. Radiofrequency ablation was applied with a balloon-based circumferential device and an endoscope mounted focal device. Patients underwent biopsy sampling of tissue from the esophagus at regular intervals to determine if all Barrett's disease had been eradicated. To be considered a complete responder, all biopsy samples had to be normal.
This study is highly relevant and represents an important contribution to the science related to Barrett's esophagus therapy, commented David S. Utley, M.D., chief medical officer for BARRX Medical. The study's strengths lie in its large number of studied patients, relatively long follow-up and objective histology endpoints. This evidence suggests that ablative therapy can be delivered by the expert endoscopist in the community setting, with an expectation for comparable results as seen in prospective trials from tertiary referral centers.
About BARRX Medical, Inc.
BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus, a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD. Its main product, the HALO360 System, provides a uniform and controlled ablation effect, which removes the diseased tissue and allows regrowth of normal cells. The HALO90 System is the company's second ablation product, which is mounted on the end of an endoscope and used to treat smaller, non-circumferential areas of disease.
A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine, studied radiofrequency ablation applied in the highest risk Barrett's population (those having dysplasia). The ablation group had a high rate of complete eradication of dysplasia and intestinal metaplasia and a significantly decreased the rate of disease progression and cancer development, as compared to the control group. In another study (AIM-II) published in Gastrointestinal Endoscopy, 98.4 percent of patients were Barrett's-free after two and a half years of follow-up.
Both HALO systems are cleared by the FDA for use in the U.S. and both have CE Mark for use in Europe. More than 30,000 procedures have been performed in over 280 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information is available at www.barrx.com.
About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academicians in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 30 - June 4, 2009 in Chicago, IL. The meeting presents approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research and technology.