W. L. Gore & Associates has enrolled the first patient in its Gore Early TIPS for Ascites Study. The patient was treated at Indiana University Hospital in Indianapolis, according to Fierce Medical Devices.
The objective of this prospective, randomized, multi-center clinical study is to evaluate whether the TIPS procedure with the GORE VIATORR TIPS Endoprosthesis improves transplant-free survival when compared to large volume paracentesis (LVP) in patients with cirrhosis of the liver and difficult to treat ascites. The study is expected to be the largest and most rigorous multi-disciplinary collaboration with hepatologists and interventional radiologists looking at early TIPS therapy. A total of 150 subjects will be enrolled at approximately 20 sites. At Indiana University Hospital the study is being led by Raj Vuppalanchi, M.D., assistant professor of clinical medicine in the division of gastroenterology/hepatology and David Agarwal, M.D., associate professor of clinical radiology in the department of radiology.
"Indiana University Hospital is pleased to be the first facility to treat a patient in this important study aimed at prolonging the lives of patients and providing more than just a bridge to transplant," said Drs. Vuppalanchi and Agarwal. "The possibility exists that we may reduce the need for alternative treatments such as medication and paracentesis; potentially improving the quality of lives for those with liver disease as well."