Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy

This is a pilot, single center, prospective, tandem study. All veteran patients with
Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas
City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A
member of the research team will approach a potential subject to discuss participation in the
study, including background of the proposed study, inclusion and exclusion criteria, benefits
and risks of the procedures and follow-up. If this is of interest to the subject, the
informed consent form is discussed and presented. The subject must sign the consent form
prior to enrollment. This form will have prior approval of the study site's Institutional
Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the
study

Eligible subjects at the participating institution who meet the inclusion criteria for this
study will be offered the opportunity to participate in this clinical trial. To ensure that
subjects are approached for potential study participation without bias, a Subject Screening
Log will be maintained. This Log will track the basic demographic information of each subject
approached for clinical trial inclusion and the resulting reason for exclusion from the
clinical study if applicable.

The duration of the study is expected to be approximately 12 months. Enrollment of Study
patients will cease when approximately 20 patients have been enrolled.

Inclusion Criteria:

- Patients age: ≥ 18 years

- Patients with BE length ≥ 1cm undergoing upper endoscopy

- Willingness to undergo both unsedated, capsule endoscopy and conventional EGD

- Ability to provide written, informed consent and understand the responsibilities of
trial participation

Exclusion Criteria:

- Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000

- Pregnant or planning a pregnancy during the study period

- Dysphagia

- Known esophageal diverticulum or stricture

- Swallowing disorder

- Known luminal, gastrointestinal stricture

- History of esophageal, gastric surgery

- Esophageal or GI motility disorder

- Subject has a known history of unresolved drug or alcohol dependency that would limit
ability to comprehend or follow instructions related to informed consent,
post-treatment instructions, or follow-up guidelines

- Known or suspected gastrointestinal obstruction, strictures, or fistulas based on the
clinical picture or pre-procedure testing and profile.

- Subjects with cardiac pacemakers or other implanted electromedical devices.

- Anticipated magnetic resonance imaging within 1 week of capsule ingestion