Evaluation of a Minimally Invasive Image-Guided Surgery System for Hepatic Ablation Procedures

This study was designed in two phases: Phase I is designed to confirm that the surgeon is
able to perform accurate liver surface registration including standard liver features used
as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level
of comfort with the procedure.

The surface of the liver will be manually swabbed with the study tracked laparoscopic probe
with landmarks noted during data collection. After registration of the liver is obtained,
the registration points obtained during this procedure will be evaluated by the surgeon by
moving the tracked laparoscopic probe over the liver surface and evaluating the location of
the tracked laparoscopic probe displayed on the guidance system three dimensional (3D)
image. The surgeon will accept or reject the registration accuracy.

The hypothesis is that the surgeon will be able to successfully acquire liver surface
registrations with a small learning curve for technique and will be able to proceed to Phase
II of the study.

Phase II contains the registration process included above but adds the additional process of
tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder
Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked
and displayed on the Pathfinder three dimensional (3D) image.

The surgeon will use ultrasound (US) guidance to locate tumor location during the
laparoscopic procedure. The images collected during this process will be recorded by
Pathfinder.