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Covidien PLC Announces Clinical Trial Data Showing Endoscopic Ablation Therapy Eliminates Precancerous Esophageal Tissue And Significantly Reduces Disease Progression

Wednesday, 22 May 2013 06:59am EDT 

Covidien PLC announced that results from a prospective, multicenter, randomized, controlled clinical trial show that endoscopic ablation therapy using the Barrx RF Ablation System is effective at eliminating Barrett`s esophagus, a pre-cancerous condition of the esophagus, and preventing disease progression. The SURF Trial (SUrveillance vs. RadioFrequency ablation) included 136 patients with Barrett`s esophagus containing confirmed low-grade dysplasia. Upon enrollment, patients were randomly assigned to receive either endoscopic ablation therapy and subsequent endoscopic observation (treatment group) or endoscopic observation alone (control group). Tissue samples (biopsies) were obtained at regular intervals after enrollment to assess for the presence of Barrett`s tissue, dysplasia and esophageal cancer. The primary endpoint of the trial was a comparison of the risk of disease progression over time between the ablation and control groups. Disease progression was defined as the development of either high-grade dysplasia or esophageal cancer during follow-up. The authors reported that endoscopic ablation therapy resulted in a 94% relative risk reduction in disease progression, compared to controls (1.5% progression in ablation group vs. 25.0% progression in control group) over a two-year follow-up period. Other endpoints included resolution of Barrett`s tissue and occurrence of adverse events. 

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