Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Barrett's Esophagus
- Esophageal Cancer
- Esophageal Squamous Dysplasia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 Cryoabla...
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).
Tracking Information
- NCT #
- NCT02534233
- Collaborators
- Pentax Medical
- Investigators
- Principal Investigator: Marcia Canto, MD, MPH Johns Hopkins University
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