Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2014-08-31
2017-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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focal cryo ablation
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
Interventions
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CryoBalloon Focal Ablation
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,
Exclusion Criteria
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope
* Inability to provide informed consent
* Esophageal cancer (T2 and above)
* Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000
* Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
18 Years
ALL
No
Sponsors
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Pentax Medical
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Kenneth K. Wang
Principal Investigator
Principal Investigators
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Kenneth Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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14-004771
Identifier Type: -
Identifier Source: org_study_id
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