Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer

The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.

Inclusion Criteria:Provision to sign and date the consent form.Stated willingness to comply with all study procedures and be available for the duration of the study.Be a male or female aged 45 years or older.Fit in the below listed inclusion criteriaInclusion Criteria for Test Population (BE and EAC subjects):Previous diagnosis of indefinite Barrett's Esophagus (IND), non-dysplastic (ND), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or esophageal adenocarcinoma (EAC)Able to swallow a Tylenol sized capsuleDiagnostic endoscopy performed within past 3 months or able to arrive early to endoscopy for EnteroTracker® to be swallowed before endoscopyInclusion Criteria for Control Population (otherwise healthy adults with no evidence of BE or EAC or other esophageal cancer but with GERD) 4. Able to swallow a Tylenol sized capsule 5. 45 years of age or older1. The majority of BE and EAC patients are age 50 years and older. Fewer than 15% of the cases are found in people younger than age 55. However current literature has suggested that there has been an increase in cases among 45-65 years old [47].6. Apparently healthy or ≥5 years of:Gastroesophageal Reflux Disease (GERD) symptoms, orGERD treated with proton pump inhibitor (PPI) therapy (whether symptom control was achieved or not), orAny combination of treated and untreated periods if the cumulative total is at least 5 yearsExclusion Criteria:History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills within 3 months of EnteroTracker® procedureInability to provide written informed consentPregnant womenPrior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy, or endoscopic mucosal resection, was performed for the treatment of BE and/or EACKnown history of esophageal varices or esophageal strictureAny contraindication, as deemed in Investigator's medical judgment, to undergoing the EnteroTracker® procedureOropharyngeal cancerHistory of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplicationHistory of esophageal motility disorderCurrently implanted Linx device