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

Barrett's Esophagus Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02249975
Study type Interventional
Source Pentax Medical
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date October 4, 2017
View Details
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