Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma

Assess the sensitivity and specificity of a panel of DNA methylation markers in the
non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a
capsule sponge device.

Inclusion criteria:

Subjects with known Barrett's Esophagus (BE).

1. Patient between the ages 18 - 85.

2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically.

3. Histology showing evidence of intestinal metaplasia with or without presence of
dysplasia.

4. Undergoing clinically indicated endoscopy.

Subjects without known evidence of BE

1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria:

Subjects with known BE.

1. 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.

2. Patients with history of esophageal or gastric resection.

Subjects with or without known evidence of BE (on history or review of medical records).

1. Pregnant or lactating females.

2. Patients who are unable to consent.

3. Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated
dysphagia.

4. Patients on oral anticoagulation including Coumadin, Warfarin.

5. Patients on antiplatelet agents including Clopidogrel, unless discontinued for 5 days
prior to the sponge procedure.

6. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a
inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 5 days
prior to the sponge procedure.

7. Patients with history of known varices or cirrhosis.

8. Patients with history of esophageal or gastric resection.

9. Patients with congenital or acquired bleeding diatheses.

10. Patients with a history of esophageal squamous dysplasia.