Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Chek-Med Systems, Inc.

Information provided by (Responsible Party):

Herbert C. Wolfsen, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01477177

First received: October 24, 2011

Last updated: February 28, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 24, 2011
Last Updated Date	February 28, 2013
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2011)	Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 12 months ] [ Designated as safety issue: No ] The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01477177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2013)	Reduction in Barrett's segment length, using the Prague classification [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ] Assessment of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] Specific complications are GI Bleeding and Perforation and Stricture and Ulceration Assessment of post-ablation symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ] The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Original Secondary Outcome Measures ^ICMJE (submitted: November 18, 2011)	Reduction in Barrett's segment length, using the Prague clasification [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ] Assessment of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] Specific complications are GI Bleeding and Perforation and Stricture and Ulceration Assessment of post-ablation symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ] The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Official Title ^ICMJE	Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Barrett's Esophagus
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Polar Wand Treatment Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia Intervention: Device: Polar Wand carbon dioxide cryotherapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	14
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01477177
Other Study ID Numbers ^ICMJE	11-004237
Has Data Monitoring Committee	Not Provided
Responsible Party	Herbert C. Wolfsen, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Chek-Med Systems, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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