Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The progression of Barrett's Esophagus will be studied over time using tethered capsule
endomicroscopy imaging and will be performed at 5 different clinical centers in the US,
namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic
Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO).
MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as
study Sponsor Investigator.

The purpose of this study is to determine the natural history of Barrett's Esophagus using
TCE in subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Inclusion Criteria:

- Subjects over the age of 18

- Subjects who are capable of giving informed consent

- Subjects with a diagnosis of BE without high grade dysplasia, intramucosal
adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,

- Subjects who had or will have a standard of care EGD within 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:

- Subjects with prior endoscopic ablation or resection treatment of BE at enrollment
visit

- Subjects with esophageal fistula and/or esophageal strictures

- Subjects with the inability to swallow capsules

- Self reported pregnancy