Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Mayo Clinic

Status: Terminated

Conditions: Barrett's Esophagus

Treatments: Device: Polar Wand carbon dioxide cryotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01477177

11-004237

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 98 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Polar Wand Treatment

Experimental group

Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Treatment:

Device: Polar Wand carbon dioxide cryotherapy