Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's
Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence
of BE will be considered for the study. Surveillance biopsies will be obtained per standard
clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have
achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study
and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will
undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year.
Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and
annually thereafter. At each follow-up visit, endoscopic data will be collected to determine
if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed
for 1 year (endpoint 1) and 3 years (endpoint 2).

Inclusion Criteria:

- Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.

- Ability to provide written, informed consent

- No significant esophagitis (LA grade
Exclusion Criteria:

- Patients for whom use of the NvisionVLE device would be in conflict with the
instruction for use.

- Prior esophageal or gastric surgical resection

- Significant esophageal stricture requiring dilatation

- Patients who require anti-coagulation for who biopsy would be contraindicated

- Patients who are known to be pregnant