N/A
Completed N=53
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Barrett's esophagus · Esophageal Squamous Dysplasia · Esophageal Cancer
Source: ClinicalTrials.gov NCT02534233 ↗
Enrolled (actual)
53
Serious AEs
17.0%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Complete Eradication of Esophageal Dysplasia — 51 Participants
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).
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 | — |
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.
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. Informational only — not medical advice.