Ensayos clínicos

Inclusion Criteria:

• Patients ≥ 18 years of age.
• Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria. 
• Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis. Patients must have a minimum of 2 therapeutic paracenteses in the 30 Days prior to enrollment.
• Not a candidate for (e.g., refused, contraindicated) Transjugular intrahepatic portosystemic shunt (TIPS) or previously implanted TIPS is permanently obstructed or non-functioning.
• Screened for esophageal varices and on optimal management. Absence of contraindications to prophylactic antibiotic use from time of pump implant.
• Life expectancy of at least 6 months following pump implant (approximately 10 months from enrollment).
• Capable of giving written informed consent, willing to comply with study procedures including the 3-month pre-implant observation period and ability to operate and charge the device. 
• Women of childbearing age should use adequate contraceptives. Reassessed at time of implant procedure (Pivotal Cohort Only): 
• Has required a minimum of 5 therapeutic paracenteses in the 3-month observation period prior to pump implant.

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 as per standard criteria, defined as 2 or more episodes over the last 6 months.
• Evidence of loculated ascites, as per imaging.
• Hepatocellular carcinoma, exceeding Milan criteria or for which RF ablation is anticipated.
• Pregnant females or females anticipating pregnancy during study period.
• Patients currently enrolled in another interventional clinical study that has not reached the primary endpoint assessment point, or (for pivotal cohort) patients who have previously had an alfapump implanted.
• Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months (corticosteroids at stable dose over the last 4 months but < 15 mg/day, or in tapering doses are allowed).
• Known or suspected hepatic or extra hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for ≥ 3 years.
• History of bladder cancer.
• BM I > 40 presenting a risk for technical difficulties for surgery or catheter implantation.
• Contraindications to general anesthesia.
• Comorbid condition or other reason (example hypertension) that may preclude stopping diuretics after enrollment.
• MELD-Na Score > 18.
• Budd Chiari syndrome (Pivotal cohort only).
• Clostridium difficile infection within the past year.  Assessed or re-assessed at time of pump implant: 
• Acute gastrointestinal hemorrhage requiring transfusions over the previous 42 days.
• Condition that prevents continued cessation of diuretic use.
• Patient condition does not allow the implant procedure to be performed within the limits of acceptable risk (e.g., cardiovascular comorbidities).
• Hepatocellular carcinoma exceeding Milan criteria or for which RF ablation is anticipated.
• ICU admission since enrollment.
• INR ≥ 2.0.
• Platelet count of < 50,000 /μL at the time of implantation, unless the platelet count is ≥ 30,000 / μL and bleeding risk can be satisfactorily addressed with means such as platelet infusion during the implant procedure and/or thrombopoietin receptor agonists.
• Bacterial peritonitis within 4 weeks of implant procedure (this includes peritonitis diagnosed at the time of intervention).
  • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of SBP within four weeks of the implant procedure date.
• Bacterascites within 4 weeks of implant procedure (this includes bacterascites diagnosed at the time of intervention).
  • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of bacterascites within four weeks of the implant procedure date.
• Serum sodium < 125 mmol/L.
• Urinary infection within the last 2 weeks.
• Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
• Evidence of renal failure, defined as serum creatinine higher than or equal to 1.5 mg/dL, in the preceding 30 days.
• Evidence of loculated ascites, as per imaging.
• Pregnant females or females anticipating pregnancy during study period.

Eligibility last updated 11/10/21.  Questions regarding updates should be directed to the study team contact.