At a glance
ClinicalIndex Comparison RecordN/ACompleted· 58 enrolled
Drug / intervention
CryoBalloondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
In Brief
A clinical study evaluating CryoBalloon for Barrett's Esophagus and 2 related conditions. Completed, enrolled 58 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPentax Medical
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedAug 2015
Primary CompletionAug 2024
Study CompletionFeb 2025
TodayJul 2026
First PostedAug 27, 2015
Enrollment StartApr 1, 2015
Primary CompletionAug 1, 2024
Study CompletionFeb 27, 2025
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 10.8 years ago
Interventions
CryoBalloondevice
Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter