Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, CSA or cryospray therapy) onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Detailed Description
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The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date. All subjects will receive narcotic analgesics to control symptoms. Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.

Official Title
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A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)

Conditions
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Barrett's Esophagus, Esophageal Cancer

Intervention / Treatment
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* Device: Cryo Spray Ablation
* Device: Cryo Spray Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age Esophagectomy planned based on clinical situation not related to this study. Deemed operable based on institutional criteria. Exclusion Criteria: Pregnant Esophageal stricture preventing passage of endoscope or catheter. Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. Refusal or inability to give consent. Concurrent chemotherapy. Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA 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. Prior radiation therapy which involved the esophagus.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Cryo Spray Ablation<br>cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds | Device: Cryo Spray Ablation<br>* Cryo Spray Ablation 4 cycles x 10 seconds treatment<br>|
| Experimental: Group 2: Cryo Spray Ablation<br>cryo spray ablation applied to healthy tissue 2 cycles x20 seconds | Device: Cryo Spray Ablation<br>* Cryo Spray Ablation 2 cycles x 20 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of Injury | histopathological findings analyzed to determine max depth of injury (mm) | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects of Subjects Receiving Cryospray Therapy. |  | End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Esophageal Cancer, Esophageal Dysplasia, Low Grade Dysplasia, High Grade Dysplasia