NCT02534233

Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).

Detailed description

Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).

Conditions

• Barrett's Esophagus
• Esophageal Squamous Dysplasia
• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	CryoBalloon	Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter

Timeline

• Start date: 2015-04-01
• Primary completion: 2024-08-01
• Completion: 2025-02-27
• First posted: 2015-08-27
• Last updated: 2025-08-01
• Results posted: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study