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

Exclusion Criteria

• •For subjects with or without known evidence of BE (on history or review of medical records)
• •* 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 for three to five days prior to the Cytosponge procedure.
• •* Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three 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 esophageal carcinoma.
• •* 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 mediastinal or esophageal cancer.