The POSEIDON Study

Summary

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.


Inclusion Criteria

  • At the time of Initial Screening:
  • Patients > 18 years of age
  • Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

ALFAPUMP® SYSTEM IN THE TREATMENT OF REFRACTORY OR RECURRENT ASCITES: A MULTICENTER SINGLE ARM WITHIN SUBJECT CROSSOVER DESIGN PIVOTAL STUDY

Details
Disease Type/Condition

Hepatology

Principal Investigator

Kuo, Alexander

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000133

ClinicalTrials.gov ID

NCT03973866

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Hepatology

Principal Investigator

Kuo, Alexander

Age Group

Adult

Phase

N/A

IRB Number

2017-AAR-010

ClinicalTrials.gov ID

NCT03973866

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?