Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples

High Risk Screening Inclusion Criteria

• Undergoing a standard of care EGD

• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD or same day as EGD).

• Willing and able to sign informed consent

• Must have chronic GERD as defined in the ACG Guidelines

• Must have at least 3 additional risk factors as defined in the ACG guidelines such as:

• Age ≥ 50

• Family history of Barrett's esophagus or esophageal adenocarcinoma

• Current or former smoker

• Obesity (BMI greater than or equal to 30 kg/m2)

• Male

• Non-Hispanic White

Exclusion Criteria

• Previous EGD for BE, with no BE identified

• Known BE or EAC

• Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm diameter))

• Known or suspected gastric or esophageal varices

• Known or suspected portal hypertension

• Taking anti-thrombotic medications that cannot be discontinued

• Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration

• Previous gastric or esophageal surgery (including Nissen fundoplication)

• History of oropharyngeal tumor

• History of myocardial infarction or cerebrovascular accident in past 6 months

• Known or suspected to be pregnant (self-report for women of child-bearing potential)

Barrett's Esophagus Inclusion Criteria

• Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})

• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET).

• Willing and able to sign informed consent

• Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.

Exclusion Criteria

• Previous EGD result was indefinite for dysplasia

• Previous endoscopic eradication therapy (EET)

• Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.))

• Known or suspected gastric or esophageal varices

• Known or suspected portal hypertension

• Taking anti-thrombotic medications that cannot be discontinued

• Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration

• Previous gastric or esophageal surgery (including Nissen fundoplication)

• History of oropharyngeal tumor

• History of myocardial infarction or cerebrovascular accident in past 6 months

• Known or suspected to be pregnant (self-report for woman of child-bearing potential)