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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Barrett's Esophagus

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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 ClinicJacksonville, Florida  32224