NovaShunt today announced
the initiation of its pivotal multi- center clinical study named PIONEER, a
Prospective, multi-center, open label, non-randomized study to Investigate
the safety and perfOrmance of the Automated Fluid ShuNt in patiEnts with
ascitEs and diuretic Resistance.
The study is designed to evaluate the safety and performance of the
Automated Fluid Shunt (AFS) System in replacing the need for paracentesis,
the standard therapy for patients with refractory ascites. Secondary
parameters in the study are concomitant reduction in the need for medication,
health care costs (hospitals stays, treatment) and patients' quality of life.
Data from the PIONEER study will be submitted to the Notified body to obtain
CE Marking which will allow NovaShunt to enter the European market. The study
is being led by the Principal Investigator Dr. Jose Such, Head of Hepatology,
University General Hospital, Alicante, Spain, and will be initialized in five
university hospitals in Europe specialized in managing patients with
refractory ascites (located in Alicante, Barcelona, Frankfurt, Regensburg and
London).
"We are very excited to begin the clinical evaluation of a novel
technology for the treatment of patients with refractory ascites," said Dr.
Such, Head of Hepatology, University General Hospital, Alicante, Spain. "As
there are many patients in our clinic suffering from decompensated cirrhosis
and the presence of ascites, the AFS System could be of great benefit for
these people."
The AFS System is an implantable, battery powered pump that automatically
and continuously removes excess fluid - known as ascites - that builds up in
the abdominal cavity in patients with liver disease and other conditions.