Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
18 Years
N/A
Both
Barrett's Esophagus
Trial Information
Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
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.
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).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction in Barrett's histology grade, using the modified Vienna classification
Outcome Description:
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Outcome Time Frame:
12 months
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
11-004237
NCT ID:
NCT01477177
Start Date:
August 2011
Completion Date:
August 2013
Related Keywords:
- Barrett's Esophagus
- Barrett's esophagus dysplasia
- Barrett Esophagus
Name | Location |
|---|---|
| Mayo Clinic | Jacksonville, Florida 32224 |
