Status:
TERMINATED
Early TIPS for Ascites Study
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Liver Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver wi...
Eligibility Criteria
Inclusion
- \> Patient has cirrhosis of the liver with portal hypertension
- \> Patient has difficult to treat ascites
- \> Patient is 18 years or older and \<70 years old at randomization
- \> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
- \> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.
Exclusion
- \> Patient has more than 6 large volume paracenteses within 90 days prior to randomization
- \> Patient is contraindicated for TIPS placement
- \> Patient has had previous TIPS placement
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01236339
Start Date
December 1 2010
End Date
March 1 2013
Last Update
June 3 2014
Active Locations (2)
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1
University of Arizona
Tucson, Arizona, United States
2
University of Maryland-Baltimore
Baltimore, Maryland, United States