Back to resultsPolar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Primary Purpose
Barrett's Esophagus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polar Wand carbon dioxide cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's esophagus dysplasia
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polar Wand Treatment
Arm Description
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction in Barrett's Segment Length, Using the Prague Classification
Assessment of Complications
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Assessment of Post-ablation Symptoms
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
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.
Full Information
NCT ID
NCT01477177
First Posted
October 24, 2011
Last Updated
April 23, 2019
Sponsor
Mayo Clinic
Collaborators
Chek-Med Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01477177
Brief Title
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Official Title
Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
enrollment much slower than anticipated, and, funding issues
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Chek-Med Systems, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's esophagus dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polar Wand Treatment
Arm Type
Experimental
Arm Description
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
Intervention Type
Device
Intervention Name(s)
Polar Wand carbon dioxide cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
Description
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction in Barrett's Segment Length, Using the Prague Classification
Time Frame
6 and 12 months
Title
Assessment of Complications
Description
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Time Frame
12 months
Title
Assessment of Post-ablation Symptoms
Description
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
Time Frame
12 months
Title
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
Description
The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
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Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
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