Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Mayo Clinic4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Barrett's Esophagus

Interventions

Polar Wand carbon dioxide cryotherapyDEVICE

Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 98 Years

Medical Language ↔ Plain English

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).

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

The reduction of Barrett's segment length and histology classification will be measured at 12 months.

Time frame: 12 months

Secondary Outcomes

Reduction in Barrett's Segment Length, Using the Prague Classification

Time frame: 6 and 12 months

Assessment of Complications

Specific complications are GI Bleeding and Perforation and Stricture and Ulceration

Time frame: 12 months

Assessment of Post-ablation Symptoms

Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat

Time frame: 12 months

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

The reduction of Barrett's segment length and histology classification will be measured at 6 months.

Time frame: 6 months

Data from ClinicalTrials.gov

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