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
|SOURCE BARRX Medical, Inc.|
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