Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01477177
• Collaborator: Chek-Med Systems, Inc. (Industry)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: Polar Wand carbon dioxide cryotherapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification [12 months]

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

Secondary Outcome Measures

1. Reduction in Barrett's Segment Length, Using the Prague Classification [6 and 12 months]

2. Assessment of Complications [12 months]

   Specific complications are GI Bleeding and Perforation and Stricture and Ulceration

3. Assessment of Post-ablation Symptoms [12 months]

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

4. Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 98 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic
• Chek-Med Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Herbert C. Wolfsen, Professor of Medicine, Mayo College of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01477177
• Other Study ID Numbers: 11-004237
• First Posted: Nov 22, 2011
• Last Update Posted: May 15, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Herbert C. Wolfsen, Professor of Medicine, Mayo College of Medicine, Mayo Clinic: Barrett's esophagus dysplasia
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Overall Participants	4
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	4 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Terminated study. Enrollment much slower than anticipated and funding issues.

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Measure Participants	0

2. Secondary Outcome

Title	Reduction in Barrett's Segment Length, Using the Prague Classification
Time Frame	6 and 12 months

Outcome Measure Data

Analysis Population Description

Terminated study. Enrollment much slower than anticipated and funding issues.

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Measure Participants	0

3. Secondary Outcome

Title	Assessment of Complications
Description	Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Terminated Study. Enrollment much slower than anticipated and funding issues

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Measure Participants	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Terminated Study. Enrollment much slower than anticipated and funding issues.

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Measure Participants	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Terminated Study. Enrollment much slower than anticipated and funding issues.

Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
Measure Participants	0

Adverse Events

Time Frame	Adverse Events were collected for 12 months
Arm/Group Title	Polar Wand Treatment
Arm/Group Description	Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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.
All Cause Mortality
	Polar Wand Treatment
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Serious Adverse Events
	Polar Wand Treatment
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Polar Wand Treatment
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.