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

NCT02534233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-08-01

Study results available
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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).

Conditions

  • Barrett's Esophagus
  • Esophageal Squamous Dysplasia
  • Esophageal Cancer

Interventions

DEVICE

CryoBalloon

Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter

Sponsors & Collaborators

Principal Investigators

  • Marcia Canto, MD, MPH · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2024-08-31
Completion
2025-02-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534233 on ClinicalTrials.gov