Status:
TERMINATED
Clinical Application of Image-Guided Liver Surgery
Lead Sponsor:
Washington University School of Medicine
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00878215
Start Date
October 24 2002
End Date
May 25 2011
Last Update
February 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110