Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

Each subject will have a biopsy performed via one of 2 different techniques: "modified wet
suction", or "slow pull" technique. A randomization process will determine which technique.
Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the
right and left lobe of the liver.

Quality of tissue obtained via the 2 different techniques will be evaluated by number of
fragments, length of specimens and number of tracts observed by the local pathologist and
compared between the tissues obtained from the two techniques. We will also note technical
success rate (ability to insert the needle twice into the liver for obtaining 2 specimens and
ability to pass into the right and left lobe of the liver).

Inclusion Criteria:

- Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying
liver disease or to determine stage, grade and presence of fibrosis for suspected
benign etiology.

- History of abnormal LFTs

- Documented history of chronic liver disease

- Question of underlying liver disease as cause of abnormal imaging or symptoms which
may be attributed to liver disorder

- Fatty liver disease

- Subjects 18 years of age or older

- Subject must be able to hold anticoagulants as per institutional standard of care

- Subjects must be deemed physically able to undergo anesthesia. This includes either
Monitored Anesthesia Care (MAC) or general anesthesia.

- Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to
participate in the study and have signed Informed Consent

- Women of child bearing potential who are not pregnant as proven by a negative
pregnancy test may be included.

Exclusion Criteria

- Subjects that are unable to tolerate anesthesia for the procedure

- Subjects 17 or under

- Subjects whose anticoagulants cannot be held

- Subjects who cannot have or refuse EUS guided procedure

- Subjects who are pregnant

- INR >1.5

- Platelets 50,000 or less

- Subjects requiring control of bleeding on initial upper endoscopy

- Subjects requiring endoscopic mucosal resection

- Subjects with large volume ascites

- Subjects requiring pancreatic biopsies