Clinical Application of Image-Guided Liver Surgery
Condition: Hepatocellular Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Intervention: Explorer Liver Image Guided System; Explorer Liver Passive Tracking; Liver surgery; Liver abalation
Intervention description: -Standard of care; -Standard of care
Intervention MeSH terms: Liver Extracts
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Image Guided Liver Surgery

Summary:

      Image-guided surgery is a new technology, which is used to create 3-D pictures that generate
      a map of the liver. This map will allow surgeons to know the exact anatomical location of
      their instruments, including instances when direct visualization is not possible. This study
      is designed to determine the safety and feasibility of using image-guided techniques for
      treatment of liver tumors. The overall goal of this study is to use image-guided surgery for
      the improvement of the surgeon's ability to remove liver tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained.

          -  Patient must be 18 years or older.

          -  Are male or non-pregnant, non-lactating females. Liver resection or ablation could be
             harmful to an unborn child therefore, is not recommended during pregnancy. After
             informed consent is obtained, women of childbearing potential will be required to have
             a blood or urine pregnancy test. 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 at least up to a month following surgery.

          -  Patients enrolled in Phase I must be candidates for surgical liver resection per a
             treating surgeon's discretion. Patients enrolled in Phase 2-3 must be candidates for
             surgical liver resection of liver mass. Patients enrolled in Phase 4 must be
             candidates for surgical ablation, but not candidates for surgical resection.

          -  Patients are scheduled clinically for use of the Pathfinder Explorer Liver Image
             Guided System which is indicated for open liver surgical procedures where
             image-guidance may be appropriate and where the patient can tolerate long apneic
             periods under general anesthesia.

        Exclusion Criteria:

          -  Any condition which, in the judgment of the investigator, might increase the risk to
             the subject or decrease the chance of obtaining satisfactory data to achieve the
             objectives of the study.

          -  Mental condition rendering the subject or his/her legal representative unable to
             understand informed consent to the nature, scope, and possible consequences of the
             study.