Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Detailed Description
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The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Official Title
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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Conditions
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Barrett's Esophagus, Esophageal Cancer

Intervention / Treatment
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* Device: Cryoballoon Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation. Patient is 18 to 80 years of age at the time of consent (inclusive). Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements. Patient's esophagectomy is clinically necessary due to reasons unrelated to this study. Patient is deemed operable per standard institutional criteria. Exclusion Criteria: Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines. Patient refuses or is unable to provide written informed consent. - - Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation. Patient has esophageal narrowing limiting access to the intended site of ablation. Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards). Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Intervention<br>CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study. | Device: Cryoballoon Ablation<br>* Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K101825)<br>* Other names: cryoablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effect | The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system. | Within 30 days of ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ablation symptoms | A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability. | Within 7 days of ablation procedure | 
| Post procedure pain | The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale. | Within 7 days of ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagectomy, Barrett's Esophagus