Spots Global Cancer Trial Database for Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

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Trial Identification

Brief Title: Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Official Title: Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Study ID: NCT02249975

Conditions

Barrett's Esophagus

Interventions

C2 CryoBalloon Focal Ablation System

Study Description

Brief Summary: The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

Detailed Description: The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm. At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol. This study is: * Prospective * Multi-center * Non-randomized