Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | April 2015 |
| End Date: | December 2019 |
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).
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).
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).
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).
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.
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