A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.

Inclusion criteria

Subjects with known Barrett's Esophagus (BE).

• Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
• Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
• Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy

Exclusion criteria

• Subjects with known BE.

• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
• Patients with history of esophageal resection for esophageal carcinoma. 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 eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
• Patients with history of known varices or cirrhosis.
• Patients with history of 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.