Trial Information

Prospective Comparison of Two EUS Processors for Imaging of the Pancreas

The endoscope is usually connected to a processor that generates an image which is viewed on
a monitor. At FH, we use a processor called Aloka 10. A new processor is being developed by
Olympus Corporation called EU-ME 2. This new processor is FDA approved, but has not been
launched commercially yet. It has been loaned to FH for evaluation. We would like to
evaluate this processor in an objective manner and hence the request for study approval.

In this study, the endoscopy during the procedure will be attached to two different
processors and images will be generated. The choice of which processor will be used first
will be at the discretion of the Endoscopist. This does not require removal and
reintroduction of the endoscope into the patient at two occasions. Only the connector will
be switched to a different processor. So there is negligible risk to the patient.

The time required for research activities will be between 5-10 minutes. Both processors
will be set up in the procedure room for the duration of this study.

The physician will then document the depth of penetration of the image (the farthest
structure seen) and image resolution (evaluating the pancreas for subtle abnormalities).
Both processors will be used for each patient. The scores for each processor will be
documented to a procedure log, using the primary endpoint described above. The CRF will not
have any patient information. Images viewed by the physician at the time of procedure will
not be saved or recorded as part of this study..

EUS will be performed in the standard fashion by one of the experienced endosonographers in
the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope
withdrawn from the patient.

Patients will then be transported to the recovery area for observation as per standard
policy. After appropriate observations are deemed satisfactory, patients will be discharged
as per unit policy.