1. Written informed consent must be obtained.
2. Patient must be 18 years or older.
3. Patients recruited are male or non-pregnant, non-lactating females. Liver resection
or ablation could be harmful to an unborn child, and therefore is not recommended
during pregnancy. All consented patients of childbearing potential will be advised
to use adequate birth control (oral, implanted, or barrier methods), along with their
sexual partners, while being considered for liver tumor resection or ablation and one
month following surgery.
4. Negative serum or urine pregnancy test result at screening in women of childbearing
potential (applies to patients without documented menopause or sterility).
5. Patients enrolled must be candidates for surgical liver resection of liver cancer
(primary or metastatic) or benign liver lesions (hemangioma, Focal Nodular
Hyperplasia, Adenoma). Liver cancer must be present on preoperative imaging study
(CT and/or MRI), if applicable.
6. Patient must be scheduled for surgical treatment of the liver cancer requiring the
removal of at least one (1) anatomic segment.
1. Any condition which, in the judgment 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 mental condition rendering them unable to understand informed
consent to the nature, scope, and possible consequences of this study.
3. Patients requiring surgical intervention that extends beyond the liver, with the
exception that extension into some adjacent structures might be allowed unless the
liver is not the primary focus of the surgery AND the potential blood loss from the
other surgical sites may jeopardize the safety of the patient. There is no absolute
rule as to what adjacent structures would be allowed, thus prior approval must be
obtained from the Medical Monitor listed above for all extrahepatobiliary surgery.
4. Patients with hereditary hematologic/coagulation disorders unrelated to their liver
5. Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
6. Use of aspirin within 7 days prior to surgery or antiplatelet agents (i.e., Plavix)
within 10 days prior to surgery or nonsteroidal anti-inflammatory medications within
48 hours prior to surgery.
7. Patients with thrombocytopenia (platelet counts below 100,000 per ml, White Count
3.0, Hemoglobin 10 or greater).
8. Patients who are currently (within the last 30 days prior to surgery) participating
in another clinical trial with any investigational drug or device.
9. Patients undergoing liver surgery as a result of trauma.
10. Patients undergoing liver surgery for the purpose of receiving a liver transplant.
11. Patients undergoing liver surgery in which there is a single minor wedge resection on
the surface of the liver.
12. Patients with established renal insufficiency (defined as creatinine greater than 2.5
mg/dl), or a condition that requires hemodialysis.