Capsule Marking Using an OFDI Capsule

A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked
to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that
allows the capsule operator to navigate the capsule as it progresses down the esophagus using
natural propulsion called peristalsis as well as to bring it back up to pulled out of the
mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in
position, two cautery marks will be made to only the superficial layers of the esophageal
mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked
regions of interest will be reimaged for confirmation of the placement of potential cautery
marks.

Immediately following the completion of the experimental procedure, the standard of care with
the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI
capsule will be compared to the images obtained by the clinical endoscopy and histology.

Inclusion Criteria:

- Patients must be undergoing an EGD.

- Patients must be over the age of 18.

- Patients must be able to give informed consent.

Exclusion Criteria:

- Patients who are on anti-platelet medications or anti-coagulation medications, and
NSAIDS at the time of procedure.

- OR patients with a history of hemostasis disorders.

- OR patients with esophageal strictures.