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

Not Applicable

Completed

• Conditions: Barrett's Esophagus; Esophageal Squamous Dysplasia; Esophageal Cancer
• Interventions: Device: CryoBalloon

• Registration Number: NCT02534233
• Lead Sponsor: Johns Hopkins University

Brief 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).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Primary Completion: 2024-08
• Study Completion: 2025-02-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.

Exclusion Criteria

• Patient unable to undergo endoscopy,
• Patients with visible esophageal mass.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CryoBalloon ablation	CryoBalloon	Patients having ablation of dysplastic tissue in esophagus.

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events (pain and dysphagia)	60 months	evaluate by patient questionnaire for change from baseline in pain on the 11 point scale (0-10) from baseline to post treatment and incidence of dysphagia (using a standardized dysphagia scoring system 0-4) collected over treatment period.
Histological evaluation of treatment zone(s) for dysplasia	60 months	evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation

Secondary Outcome Measures

Name	Time	Method
Histological evaluation of treatment zone for intestinal metaplasia (BE patients)	60 months	evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States