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Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's Esophagus
Date:6/1/2009

Large multi-center trial conducted in a community practice setting demonstrates comparable outcomes as trials conducted in predominantly tertiary academic centers

SUNNYVALE, Calif., June 1 /PRNewswire/ -- 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 ter
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SOURCE BARRX Medical, Inc.
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