The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
California Pacific Medical
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Baylor University Healthcare System
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
VCU Medical Centre
Richmond, Virginia, United States
Toronto General Hospital
Toronto, Ontario, Canada
Incidence and severity of serious adverse events related to the device and its implantation.
Time frame: 12 months
Assess the overall requirement for large volume paracentesis
Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events • Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events
Time frame: 12 months
Nutritional status
Nutritional status o evaluate changes in serum prealbumin
Time frame: 12 months
Evaluate patient quality of life
Evaluate patient quality of life * chronic liver disease questionnaire (CLDQ) * PLD questionnaire * ECOG performance status
Time frame: 12 months
Overall survival
Time frame: 12 months
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