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Presentation of Landmark Clinical Trial Evaluating Endoscopic Treatment for Pre-cancerous Condition of Esophagus
Date:5/19/2008

asia (minor pre-cancerous changes) or high-grade dysplasia (severe pre-cancerous changes), and then finally cancer. The present study included patients with Barrett's containing low- or high-grade dysplasia.

Patients in the study were randomly assigned to receive either endoscopic ablation therapy using the HALO ablation system (BARRX Medical, Inc.), or, a sham (placebo) intervention. Tissue samples, or biopsies, were subsequently taken at regular intervals over the next year to assess for Barrett's, dysplasia, and / or cancer. Comparative pathology results at one year served as the primary outcome for the trial. The study endpoints were the disappearance of dysplasia, as well as the more rigorous endpoint of complete eradication of all Barrett's tissue. In the latter case, the esophageal lining is deemed normal, with no sign of residual abnormal cells.

At one year follow-up, the treatment group had a much higher complete eradication rate for both dysplasia and Barrett's cells as compared to the untreated sham group, with statistical significance. In fact, more than three quarters of the treated patients had no detectable Barrett's at the end of the treatment period, compared to sham patients (all of whom still had Barrett's.) Further, the progression rate to higher grades of dysplasia and esophageal cancer was significantly lower in the treatment group as compared to the sham group.

About BARRX Medical and the HALO Ablation Technology

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 flagship product, the HALO360 System, provides uniform and controlled therapy at a consistent depth, which can remove Barrett's esophagus and allow the re-growth of normal cells. In the largest clinical trial conducted and published to date (the AIM Trial), 98.4 percent of patients were Barrett's-free after
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SOURCE BARRX Medical, Inc.
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