Clinical Application of Image-Guided Liver Surgery



Status:Terminated
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/15/2018
Start Date:October 24, 2002
End Date:May 25, 2011

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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.


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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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from
Saint Louis, MO
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