NCT02514525

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DEVICE	CryoBalloon Ablation System	CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.

Timeline

• Start date: 2016-03-01
• Primary completion: 2024-03-01
• Completion: 2025-12-01
• First posted: 2015-08-03
• Last updated: 2025-01-13

Locations

11 sites across 1 country: United States