Clinical Application of Image-Guided Liver Surgery
Stopped early · Phase 2
Conditions studied: Hepatocellular Cancer
In brief
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.
Key facts
- Study ID
- NCT00878215
- Run by
- Washington University School of Medicine
- People needed
- 40
- Starts
- 2002-10-24
- Expected to finish
- 2011-05-25
- Last updated by the study team
- 2018-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.