Cytosponge Adequacy Study Evaluation II

This is a cross-sectional study of subjects with Barrett's esophagus (BE) to assess the
utility of the Cytosponge device as a non-endoscopic method for collecting surface cells from
the esophagus. This study will enroll 2 groups of subjects: 1) Subjects presenting for
routine endoscopic BE surveillance examinations (n=120), and 2) Subjects with
gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for
BE (n=55). After informed consent, and on the same day as the endoscopic procedure, the
subject will undergo administration of the Cytosponge device and complete a questionnaire.
The subject will then undergo routine upper endoscopy, with assessment of BE (where
applicable), and biopsy per accepted surveillance or screening recommendations. The
Cytosponge will be placed in fixative and shipped to an accredited pathology laboratory for
embedding in paraffin and hematoxylin and eosin (H&E) staining to assess the adequacy of the
specimen. Further evaluation of the specimen may be performed using trefoil factor 3 (TFF3).
If the Cytosponge tissue specimen is inadequate, the subject will be recalled for a repeat
sponge procedure (not endoscopy) 30 days later. Routine care tissue biopsies will undergo
standard processing and H&E staining at the home institution, with assessment by expert
gastrointestinal pathologists. Subjects will be contacted via phone 7 days (+/- 2 days) after
Cytosponge administration to complete additional questionnaires and assess adverse events.

Inclusion Criteria:

1. Male or female patients, age 18 and above.

2. Able to read, comprehend, and complete the consent form.

3. Clinically fit for an endoscopy.

4. Previous confirmed diagnosis of BE with intestinal metaplasia. Prague classification
of at least of at least one circumferential centimeter of BE or a total BE segment
length of at least 3 centimeters (BE arm) in last 3 years

5. Self-reported heartburn or regurgitation on at least a monthly basis for at least 6
months (GERD arm).

Exclusion Criteria:

1. Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor,
or ongoing symptoms of dysphagia.

2. Any history of esophageal varices, or active stricture.

3. Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or
low molecular weight heparin (requires discontinuation of medication 5 days prior to
and 6 days after EGD).

4. Known bleeding disorder.

5. Individuals who have had a myocardial infarction or any cardiac event < 6 months prior
to enrollment.

6. Individuals who have had a cerebrovascular event < 6 months prior to enrollment in
which swallowing was affected.

7. Prior ablative or resection therapy of the esophagus including radiofrequency ablation
(RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection,
and other ablation therapies.

8. Any history of esophageal surgery, except for uncomplicated fundoplication.

9. Do not need upper endoscopy as part of patient management.

10. Planned ablation therapy (including endoscopic mucosal resection and submucosal
dissection) within 3 days after Cytosponge administration.