Status:
TERMINATED
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Chek-Med Systems, Inc.
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-98 years
Phase:
NA
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...
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 carbo...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01477177
Start Date
August 1 2011
End Date
April 1 2014
Last Update
May 15 2019
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224