Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
United States: Institutional Review Board
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