Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100
subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.

Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the
time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions
(baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by
the treating physician that additional EGDs are needed, for extended follow-up or treatment,
capsule imaging will be performed whenever possible.

Patients will have received written information prior to the day of the capsule procedure and
patients will have another chance to discuss the procedure with the study coordinator and
clinical study staff during the consent process prior to the capsule procedure. Participation
in this study is completely voluntary, and the patient can stop the procedure at any time.

For each of the imaged patients, inclusion criteria and clinical characteristics such as age,
sex, body mass index (BMI), current medication regimen, smoking history and GI related
history will be recorded in the clinical form.

Subjects will be seated and asked to sip water to facilitate swallowing the capsule.

The device will be operated by experienced study staff trained in the procedure such as a
registered nurse or one of the endoscopist co-investigators in this study. Emergency phone
and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be
accessible during the procedure if any problems are encountered that require their expertise.

Imaging will be performed in the same manner as in our other current IRB approved tethered
capsule endomicroscopy studies. The capsule position will be controlled manually via the
tether outside of the subject's mouth by the catheter operator. Recorded real-time
cross-sectional images displayed on the monitor and distance marks on the tether will be used
for confirmation of capsule position in the esophagus. Images will be viewed in real time to
determine when the capsule has reached the stomach. The resistance of the tether can also
give information of the cardia position. Once in the stomach, the capsule will be gradually
pulled back up through the esophagus to the mouth, also while imaging. The capsule may be
repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be
asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in
length) to obtain the best distal esophageal images. It is expected that the maximum
experimental time including swallowing the capsule, the imaging procedure, and removal of the
capsule will take approximately 10 minutes in total.

Inclusion Criteria:

- Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or
esophageal adenocarcinoma, confirmed by endoscopic biopsy,

- Patients over the age of 18

- Patients who are capable of giving informed consent

- Patients who had or will have a standard of care EGD within 9 to 15 months

- Subjects must have no solid food for at least 4 hours prior to the procedure, and only
clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

- Patients with prior endoscopic ablation or resection treatment of BE

- Patients with esophageal fistula and/or esophageal strictures with a luminal stricture
diameter that is smaller than the diameter of the capsule

- Patients with the inability to swallow capsules.

- Pregnancy, according to patient information