Barrett's Esophagus Clinical Trial
Official title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
This is a feasibility study without a primary study hypothesis or statistical comparison.
The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken. Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following: - Deployment ease/scope compatibility. - Device malfunctions. - Time of catheter deployment. - Adverse events. - Stricture formation at 6 to 8 weeks. - Patient Pain. - Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus. ;
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