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 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.
For the purposes of the study, subjects will be enrolled following the inclusion/exclusion
1. Written informed consent must be obtained.
2. Patients enrolled must be undergoing a staging laparoscopy for with the intention for
conversion to laparotomy.
3. Patient must be 18 years of age or older.
4. Women of childbearing age without documented evidence of menopause or sterility must
have a negative serum or urine pregnancy test at the time of screening.
1. Any condition which, in the judgement of the clinical investigator or his designee,
might increase the risk to the subject or decrease the chance of obtaining satisfactory
data to achieve the objectives of the study.
2. Patients that have a condition rendering them unable to understand the nature, scope
and possible consequences of this study and therefore unable to give proper consent.
3. Patients with Cirrhosis of the liver classified as Child-Pugh B or C.
4. Patients undergoing liver surgery for the purpose of receiving a liver transplant.
5. Patients with established renal insufficiency (defined as creatinine greater than 2.5
mg/dl), or a condition that requires hemodialysis.
A total study population will include 20 subjects that complete both the laparoscopic and
open liver procedures scheduled.
Observational Model: Case-Only, Time Perspective: Prospective
The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data.
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.
William Jarnagin, M.D.
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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