Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
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
Observational Model: Case-Only, Time Perspective: Prospective
The number of accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit. The performance of accurate physical-to-image registrations obtained during laparoscopic procedures will be compared with open liver registrations obtained from previous validation studies during open liver procedures.
David A. Geller, M.D.
UPMC, Montefiore Hospital Liver Cancer Center
United States: Institutional Review Board
|UPMC, Montefiore Hospital Liver Cancer Center||Pittsburg, Pennsylvania 15213|