EsoCheck and EsoGuard for the Detection of Barrett's Esophagus in Patients without Chronic Gastroesophageal Reflux Disease Symptoms

Inclusion Criteria

• Adults who have not had prior esophagogastroduodenoscopy (EGD) within past ten years, and are able to provide informed consent and who have:
• No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
• No significant dysphagia or odynophagia; but who do have:
• Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD)
• Adults ≥ age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size ≥ 35 inches for women and ≥ 40 inches for men), current smoker or smoking history ≥ 10 pack years, white race, male sex, confirmed history of BE/esophageal adenocarcinoma (EAC) in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria
• Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• History of prior EGD procedure in past ten years
• 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 coagulopathy with international normalized ratio (INR) > 1.5
• 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