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 30 subjects: 10 in Phase I and 20 in Phase II that
complete the laparoscopic procedure scheduled.
Observational Model: Case-Only, Time Perspective: Prospective
Phase I: The number of accurate liver surface registrations obtained in the laparoscopic environment providing the surgeon with a comfort level of adding the registration procedure to the scheduled laparoscopic surgical ablation procedure.
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 evaluated and accepted by the surgeon during the procedure.
David A. Gerber, M.D.
UNC Cancer Center
United States: Institutional Review Board
|UNC - CH Department of Surgery||Chapel Hill, North Carolina 27599-7211|