Liver Cancer Clinical Trial
Official title:
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
This study was 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 procedure. The hypothesis is that there will be no clinically relevant
difference between the error measurements obtained during the laparoscopic procedures in
this study when compared with those obtained during previous open liver registration
studies.
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 Pathfinder System used during this study is used for data collection purposes only and
is not used during the surgical procedure as an image guided system.
Preoperative computed tomography (CT) scans, obtained as standard of care, will be used to
generate the image guided liver system 3D liver surface images used during the study.
During the laparoscopic procedure, the Pathfinder device will be inserted through the
standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.
A total study population will include 20 subjects that complete the laparoscopic procedure
scheduled.
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Observational Model: Case-Only, Time Perspective: Prospective
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