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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Barrett's Esophagus, Esophageal Squamous Dysplasia, Esophageal Cancer

Intervention / Treatment
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* Device: CryoBalloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CryoBalloon ablation<br>Patients having ablation of dysplastic tissue in esophagus. | Device: CryoBalloon<br>* Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter<br>* Other names: Cryoablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological evaluation of treatment zone(s) for dysplasia | evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation | 60 months | 
| Number of patients with treatment-related adverse events (pain and dysphagia) | evaluate by patient questionnaire for change from baseline in pain on the 11 point scale (0-10) from baseline to post treatment and incidence of dysphagia (using a standardized dysphagia scoring system 0-4) collected over treatment period. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological evaluation of treatment zone for intestinal metaplasia (BE patients) | evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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barrett's esophagus with dysplasia, early esophageal cancer