The POSEIDON Study
Condition: Ascites, liver cirrhosis
Key Inclusion Criteria
- At least 18 years old
- Cirrhosis of the liver
- Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis (a procedure in which fluid in the abdomen is removed by inserting a needle and drawing out the fluid)
Key Exclusion Criteria
- Renal failure defined as serum creatinine higher than or equal to 1.5 mg/dL
- More than one episode of spontaneous bacterial peritonitis over the previous 6 months
- Recurrent urinary infections
Full Study Name
Alfapump System in the Treatment of Refractory or Recurrent Ascites: a Multicenter, Single-Arm, Non-Randomized Within Subject Crossover Design, Pivotal Study-The POSEIDON Study (IRB no. 00000133)
This study focuses on individuals who have been diagnosed with refractory or recurrent ascites due to liver cirrhosis (a condition in which scarring of the liver causes a buildup of fluid in the abdomen). The purpose of the study is to determine whether an investigational device called the Alfapump System can effectively move excess peritoneal fluid from a patient’s abdomen into the bladder, where it can be eliminated through normal urination. Researchers aim to learn whether the Alfapump can reduce the need for repeat paracentesis (a procedure in which fluid in the abdomen is removed by inserting a needle and drawing out the fluid) and increase quality of life for individuals with ascites due to liver cirrhosis. The study will evaluate the safety of the device, as well as its impact on patients.
The Alfapump System consists of an implanted pump with rechargeable battery, implanted peritoneal catheter that goes into the abdomen (peritoneal cavity), implanted bladder catheter, and external hand-held charging device.