Early TIPS for Ascites Study

Stopped early · Not applicable

Conditions studied: Liver Cirrhosis, Portal Hypertension, Ascites

In brief

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 with portal hypertension and difficult to treat ascites.

Key facts

Study ID

NCT01236339

Run by

W.L.Gore & Associates

People needed

26

Starts

2010-12-01

Expected to finish

2013-03-01

Last updated by the study team

2014-06-03

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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.

You may not qualify if…

• > 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Maryland-Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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