Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

PRIMARY OBJECTIVES:

I. To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in
balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and
false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve
the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable
balloon for the esophagus over 30-60 minutes followed by a standard
esophagogastroduodenoscopy (EGD).

After completion of study, patients with serious adverse events are followed up until
resolution, stabilization, or until it has been determined that the study treatment or
participation is not the cause.

Inclusion Criteria:

- Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)

- Patients can provide informed consent

- Patients have no known coagulopathy and no known history of esophageal varices

Exclusion Criteria:

- Patients are not undergoing clinically indicated EGD

- Patients have known coagulopathies or history of esophageal varices

- Patients do not have the ability to give informed consent