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Spots Global Cancer Trial Database for Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

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Trial Identification

Brief Title: Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

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

Study ID: NCT01477177

Study Description

Brief Summary: 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic, Jacksonville, Florida, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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