Pilot Study of EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for Evaluation of Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus that can lead to remodeling and stricture formation. To assess response to therapy, upper endoscopy (EGD) with biopsies is performed. This can lead to multiple EGDs, which are invasive and costly. There is currently a substantial unmet need for a less invasive assessment of disease activity. There have been a few noninvasive testing modalities suggested, including the esophageal string test and Cytosponge, each with their own set of limitations. Another potential promising device is EsoCheck. This is an encapsulated balloon that can be easily swallowed to collect esophageal cells. It is well tolerated and, in Barretts esophagus, detected metaplasia with 91.7% specificity. The aims of this study are to determine the feasibility and safety of EsoCheck compared with EGD and sensitivity and specificity of brush cytology and EsoCheck in a prospective cross-sectional pilot study of adult patients at the University of Pennsylvania with known EoE. This will be a prospective cross-sectional pilot feasibility study at the University of Pennsylvania. Inclusion criteria include adult patients greater than or equal to 22 years of age with known or suspected EoE scheduled for a clinically indicated upper endoscopy. Consecutive patients will be approached for consent until a total of 10 patients are enrolled. Esocheck will be performed up to 2 hours prior to the EGD. Exclusion criteria include known or suspected contraindication for esophageal intubation, esophageal stricture with inability to pass an endoscope, history of esophageal perforation, history of esophageal resection, esophageal diverticula, esophageal fistula, pill dysphagia, pill swallowing phobia, food impaction, esophageal varices, coagulopathy, active anticoagulation or antithrombotics, active GI bleeding and pregnancy. The primary study objective is to assess the feasibility and safety of EsoCheck compared to EGD with biopsies.