N/A N=53 Treatment

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

Barrett's Esophagus · Esophageal Squamous Dysplasia · Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02534233 ↗

Enrolled (actual)

Serious AEs

17.0%

Results posted

Aug 2025

Primary outcome: Primary: Number of Participants With Complete Eradication of Esophageal Dysplasia — 51 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CryoBalloon (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Eradication of Esophageal Dysplasia	51	—
PRIMARY Treatment-related Adverse Events Assessed by Pain Scale	1; 0; 0	—
PRIMARY Treatment-related Adverse Events Assessed by Stricture Rate	6	—
SECONDARY Number of Participants With Complete Eradication of Intestinal Metaplasia	35	—

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02534233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.