Clinical Trial: Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 12 months ]

The reduction of Barrett's segment length and histology classification will be measured at 12 months.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in Barrett's segment length, using the Prague classification [ Time Frame: 6 and 12 months ]
  • Assessment of complications [ Time Frame: 12 months ]
    Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
  • Assessment of post-ablation symptoms [ Time Frame: 12 months ]
    Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
  • Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 6 months ]
    The reduction of Barrett's segment length and histology classification will be measured at 6 months.


Original Secondary Outcome:

  • Reduction in Barrett's segment length, using the Prague clasification [ Time Frame: 6 and 12 months ]
  • Assessment of complications [ Time Frame: 12 months ]
    Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
  • Assessment of post-ablation symptoms [ Time Frame: 12 months ]
    Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
  • Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 6 months ]
    The reduction of Barrett's segment length and histology classification will be measured at 6 months.


Information By: Mayo Clinic

Dates:
Date Received: October 24, 2011
Date Started: August 2011
Date Completion:
Last Updated: April 8, 2014
Last Verified: April 2014