Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE

Inclusion Criteria

• Men aged 50 years old and older
• ≥5 years either of
• GERD symptoms,
• GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
• any combination of treated and untreated periods, as long the cumulative total is at least 5 years
• No solid foods eaten for at least 2 hours prior to EsoCheck procedure
• One or more of the following risk factors:
• Caucasian race
• Current or past history of cigarette smoking
• BMI of at least 30 kg/m2
• First-degree relative with BE or EAC -

Exclusion Criteria

• History of prior EGD procedure
• Inability to provide written informed consent
• On anti-coagulant drug(s) that cannot be temporarily discontinued
• Known history of esophageal varices or esophageal stricture
• Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history 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 of uncomplicated surgical fundoplication procedure
• History of myocardial infarction or cerebrovascular accident within past 6 months
• History of esophageal motility disorder
• Currently implanted Linx device