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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System — ColdPlayIII  

Barrett Esophagus Clinical Trial

Official title:
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

Clinical Trial Summary

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Clinical Trial Description

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02514525
Study type Interventional
Source Pentax Medical
Contact
Status Active, not recruiting
Phase N/A
Start date March 2016
Completion date June 2023
View Details
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