Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

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

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.

Study Overview

• Status: Terminated
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Device: Polar Wand carbon dioxide cryotherapy

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 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
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polar Wand Treatment; Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia	Device: Polar Wand carbon dioxide cryotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Barrett's Segment Length, Using the Prague Classification		6 and 12 months
Assessment of Complications	Specific complications are GI Bleeding and Perforation and Stricture and Ulceration	12 months
Assessment of Post-ablation Symptoms	Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat	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.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Chek-Med Systems, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Barrett's esophagus dysplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 11-004237