Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Study Overview
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Brief Summary
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The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.

Detailed Description
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Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.

Official Title
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Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Device: Polar Wand carbon dioxide cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment. Previous fundoplication surgery is permitted Age 18 years to 98 years Ability to provide written, informed consent Exclusion Criteria: Inability to obtain biopsies due to anticoagulation, varices, etc. Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax. Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures. Worse than Grade B erosive esophagitis Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 98 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: Polar Wand Treatment<br>Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia | Device: Polar Wand carbon dioxide cryotherapy<br>* Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification | The reduction of Barrett's segment length and histology classification will be measured at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Barrett's Segment Length, Using the Prague Classification |  | 6 and 12 months | 
| Assessment of Complications | Specific complications are GI Bleeding and Perforation and Stricture and Ulceration | 12 months | 
| Assessment of Post-ablation Symptoms | Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat | 12 months | 
| Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification | The reduction of Barrett's segment length and histology classification will be measured at 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's esophagus dysplasia