Phase
Condition
Barrett's Esophagus
Esophageal Disorders
Heartburn
Treatment
Esophago-gastro-duodenoscopy (EGD)
EsoCheck/EsoGuard (EC/EG)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
No known coagulopathy, no known esophageal varices.
No significant dysphagia or odynophagia
Absence of chronic GERD, defined as five or more years of heartburn or regurgitationwith symptoms at least once a week when not on medications for GERD symptoms.
Subjects to qualify must meet criterion 3, be over age 50, and have two additionalrisk factors for BE (white race, central obesity defined as waist size >35 inchesfor women and >40 inches for men, male gender, current smoker or smoking history >10pack years, confirmed family history in at least two members with one being a firstdegree relative).
Exclusion
Exclusion Criteria:
History of prior EGD procedure
Inability to provide written informed consent
History of weekly of more frequent heartburn or regurgitation for five or more years
On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathywith international normalized ratio (INR) > 1.5
Known history of esophageal varices or esophageal stricture
Any contraindication, as deemed inInvestigator's medical judgment, to undergoing theEsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken,including but not limited to due to comorbidities such as coagulopathy or a knownhistory of esophageal diverticula, esophageal fistula and/or esophageal ulceration
History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia),including swallowing pills
Oropharyngeal tumor
History of esophageal or gastric surgery, with exception on uncomplicated surgicalfundoplication procedure
History of myocardial infarction or cerebrovascular accident within past 6 months
Study Design
Study Description
Connect with a study center
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio 44106-5065
United StatesActive - Recruiting
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