Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study

Detailed Description
-----------------
The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Official Title
-----------------
Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Device: CryoBalloon™ Full Ablation System
* Device: CryoBalloon™ Swipe Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation Older than 18 years of age Requires a clinically necessary esophagectomy for esophageal cancer or other indications. Exclusion Criteria: Patient has esophageal narrowing limiting access to the intended sites of ablation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CryoBalloon™ Full Ablation System<br>To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. | Device: CryoBalloon™ Full Ablation System<br>* Tissue Ablation using CryoBalloon™ Full Ablation System<br>* Other names: CryoBalloon Ablation System (360);|
| Other: CryoBalloon™ Swipe Ablation System<br>To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. | Device: CryoBalloon™ Swipe Ablation System<br>* Tissue Ablation using CryoBalloon™ Swipe Ablation System<br>* Other names: CryoBalloon Ablation System (90);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the CryoBalloon™ Full and Swipe Ablation System | Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System | 2 weeks | 
| Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems | Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment. Dose response by effect of ablation to submucosa: 0: Normal Inflammatory cell infiltration Separation with inflammation Edema and Necrosis | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance: Average Procedure Time | Average Procedure time as measured from start to finish of ablation. | Minutes from start to end of procedure | 
| Device Performance: Ease of Deployment of Device | Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best) | Minutes, from start to end of procedure |