WavSTAT® Optical Biopsy System to Target Esophageal Biopsies

In the clinical portion of this prospective study, the algorithm developed in the
preclinical evaluation will be blindly tested using the pathologists' assessment of the
biopsies as a gold standard to determine the clinical sensitivity and specificity of the
WavSTAT Optical Biopsy System to identify dysplastic or cancerous tissue in the esophagus.
In addition, the endoscopist's unaided clinical sensitivity and specificity to identify
dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual
assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia
or cancer prior to performing the biopsy The endoscopist's assessment will be correlated and
compared with the pathologist's interpretation. The clinical utility of the WavSTAT System
to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the
esophagus will be evaluated by testing the hypothesis that the sensitivity of a
WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone.

Inclusion Criteria:

- The patient is between 18 and 80 years of age.

- The patient is willing to sign an informed consent form.

- The patient is a candidate for endoscopic examination

- Female patients of child-bearing age, uncertain of pregnancy status, must have a
negative pregnancy test.

Exclusion Criteria:

- The patient has congenital deformities, which preclude a physical biopsy procedure
during endoscopy.

- The patient is pregnant or nursing by admission.

- The patient has other contraindications for physical biopsy.