Clinical Trial: ALFApump System Versus Standard of Care in Ascites Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

Brief Summary: This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

Detailed Summary:
Sponsor: Sequana Medical AG

Current Primary Outcome: Paracentesis free survival [ Time Frame: 6 months ]

Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres


Original Primary Outcome: Paracentesis free survival [ Time Frame: 6 months ]

Paracentesis-free survivial, defined as time to first large volume therapeutic paracentesis > 5 litres


Current Secondary Outcome:

  • Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system [ Time Frame: 6 months ]
    Cirrhosis-related complications
  • Quality of Life [ Time Frame: 6 months ]
  • Body weight [ Time Frame: 6 months ]
  • Nutritional profile [ Time Frame: 6 months ]
  • Resource utilisation [ Time Frame: 6 months ]
  • Survival [ Time Frame: 6 months ]
  • Assess the need for repeat evacuation paracentesis [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system [ Time Frame: 6 months ]

    Cirrhosis-related complications as defined below:

    • Hepatic Encephalopathy
    • Hepatorenal Syndrome
    • Spontaneous Bacterial Peritonitis (SBP)
    • Variceal haemorrhage
    • Mortality
  • Quality of Life [ Time Frame: 6 months ]
    Evaluate patient quality of life (via the questionnaires SF-36 and CLDQ)
  • Body weight [ Time Frame: 6 months ]
    Evaluate changes in body weight
  • Nutritional profile [ Time Frame: 6 months ]
    Changes to circumference of arm and tricipital skinfold, as markers of the nutritional profile of patients
  • Resource utilisation [ Time Frame: 6 months ]
    Hospital centre costs associated with managing study patients
  • Survival [ Time Frame: 6 months ]
  • Assess the need for repeat evacuation paracentesis [ Time Frame: 6 months ]


Information By: Sequana Medical AG

Dates:
Date Received: January 31, 2012
Date Started: August 17, 2012
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017