Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Stopped early · Not applicable

Conditions studied: Barrett's Esophagus

In brief

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.

Key facts

Study ID

NCT01477177

Run by

Mayo Clinic

People needed

4

Starts

2011-08-01

Expected to finish

2014-04-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older, up to 98. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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