Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

Inclusion Criteria:

• Subjects with known or suspected Barrett's esophagus (BE) (cases)

• Patients between the ages of 18-90.

• Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspectedBE in medical record.

• Histology showing evidence of intestinal metaplasia with or without presence ofdysplasia or suspected BE in medical record.

• Undergoing clinically indicated endoscopy.

• Subjects without known history of BE (controls)

• Undergoing clinically indicated diagnostic endoscopy

Exclusion Criteria:

• For subjects with or without known evidence of BE (on history or review of medicalrecords)

• Pregnant or lactating females.

• Patients who are unable to consent.

• Patients with current history of uninvestigated dysphagia.

• History of eosinophilic esophagitis, achalasia.

• Patients on oral anticoagulation including Coumadin, Warfarin.

• Patients on antiplatelet agents including Clopidogrel, unless discontinued forthree to five days prior to the Cytosponge procedure.

• Patients on oral thrombin inhibitors including Dabigatran and oral factor Xainhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued forthree to five days prior to the Cytosponge procedure.

• Patients with history of known esophageal or gastric varices or cirrhosis.

• Patients with history of surgical esophageal resection for esophagealcarcinoma.

• Patients with congenital or acquired bleeding diatheses.

• Patients with a history of esophageal squamous dysplasia.

• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary,stomach, or duodenum) within 5 years prior to study enrollment.

• Patient has received chemotherapy class drugs or radiation to treat mediastinalor esophageal cancer.