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

Not Applicable

Completed

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

• 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: 2015-04-01
• 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
• Results First Submitted: 2025-06-05
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Results First Posted: 2025-08-01
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Eradication of Esophageal Dysplasia	12 months	Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).
Treatment-related Adverse Events Assessed by Pain Scale	1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)	Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort.; Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.
Treatment-related Adverse Events Assessed by Stricture Rate	Up to 12 months	Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Eradication of Intestinal Metaplasia	12 months	Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation

Trial Locations

Locations (1)

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