Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2013-06-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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failure to respond to RF ablation
patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
* Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
* Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment
Exclusion Criteria
* Life expectancy less than 12 months
* Pregnancy
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope and suction tubing
* Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
* Esophageal cancer (T2 and above)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Kenneth K. Wang
Kathy and Russ VanCleve Professor of Gastroenterology Reserach
Principal Investigators
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Kenneth K Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-006030
Identifier Type: -
Identifier Source: org_study_id