The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy

Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will
be enrolled. Patients undergoing surveillance for Barrett's esophagus with no dysplasia or
low-grade dysplasia are candidates for participation, but patients with known high-grade
dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for
these conditions are not candidates for participation. Informed consent will be obtained from
every patient prior to enrollment.

Patients will be randomized prior to starting the procedure. Each patient will receive a
randomization code at the time of randomization. It is important that the randomization code
be included in the Case Report Form submitted with each patient, and will represent the
unique deidentified code for each patient's data for inclusion in the study database.

At endoscopy, all patients will be initially assessed for the presence of an endoscopic
suspicious lesion using white light and if appropriate narrow band imaging or similar
enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then
either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the
columnar-lined esophagus based on the assigned randomization away from the area of targeted
biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori
infection and the presence of intestinal metaplasia.

Targeted forceps biopsies of any endoscopic suspicious area will be placed in a separate
pathology bottle from those obtained from 4-Quadrant Random Forceps Biopsy and analyzed
separately as well.

All the components needed to perform WATS biopsies are included in a kit with complete
written instructions.

WATS specimens will be analyzed by CDx Diagnostics. Investigator will ship the WATS specimens
to CDx Diagnostics in accordance with CDx's instructions. Forceps biopsies will be analyzed
by institution's pathology department and the pathology department of each additional site
participating in the Study per standard protocol.

The Investigator will determine appropriate follow-up of patients with and without IM or
dysplasia detected by WATS or FB per standard individual and / or institution protocol.

Investigator and all investigators at the additional sites will supply the study coordinator
with de-identified data for each specimen, such de-identified data including patient
demographics, endoscopic findings, and results of the FB of GEJ, antrum plus / minus
esophagus. Study Data will be maintained on a secure database by the study coordinator during
the Term and for six years thereafter.

Biopsies with intestinal metaplasia or dysplasia may be reviewed by a central pathologist to
confirm the original pathologic interpretation when there is a discrepancy between WATS and
FB that is greater than 10%.

Inclusion Criteria:

- Both males and females at least 18 years of age undergoing routine upper endoscopy to
evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal
strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric
issues).

- Institutional Review Board (IRB)-approved consent must be signed by patients prior to
participating in this study.

Exclusion Criteria:

- Patients who do not undergo either FB or WATS biopsy

- Patients with inadequate WATS or FB specimens

- Known history of high-grade dysplasia or adenocarcinoma

- Prior history of endoscopic resection or ablation for Barrett's with high-grade
dysplasia or adenocarcinoma