TerminatedNot Applicable

Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Stopped: enrollment much slower than anticipated, and, funding issues

United States4 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range18 Years – 98 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification

Timeframe: 12 months

Trial details

NCT IDNCT01477177

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2019-04-23

View on ClinicalTrials.gov More Barrett's Esophagus trials