Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer D... (-grade dysplasia or high-grade dysplasia...)

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Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer Development

Date:5/27/2009

-grade dysplasia or high-grade dysplasia, and then finally cancer. The present study included patients with the later stages of low- and high-grade dysplasia.

Beginning in 2006, the AIM Dysplasia Trial enrolled 127 patients having a diagnosis of Barrett's esophagus with dysplasia, the most advanced stage of this condition. Patients were randomly assigned to receive either endoscopic ablation with the HALO system or a sham intervention (control, no treatment). Tissue samples (biopsies) were obtained from the esophagus at regular intervals for one year after enrollment to assess for the presence of early Barrett's, dysplasia, and esophageal cancer. Comparison of the biopsy results at one year served as the primary outcome for the trial. The study endpoints were the eradication of all early Barrett's and, separately, all dysplasia in each group, as well as occurrence of new esophageal cancers.

At one-year follow-up, patients treated with ablation had a significantly higher complete eradication rate for both early Barrett's and dysplasia as compared to the control group. More than three quarters of treated patients had no detectable Barrett's at the end of the treatment period, compared to sham patients where 98% had persistent disease. The overall rate of disease progression to more severe forms of dysplasia and cancer was significantly lower in the ablation treatment group (3.6%) as compared to the control group (16.3%). In the highest risk cohort (high-grade dysplasia), ablative therapy significantly reduced the risk of progression to cancer by nearly 90% compared to control (2.4% in treated patients versus 19.0% in untreated controls).

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 HALO
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Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer D...(-grade dysplasia or high-grade dysplasia...),Health