Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)

Running, not enrolling · Not applicable

Conditions studied: Ascites

In brief

The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. An analysis will be conducted to support an application for device approval when a minimum of 40 treated pivotal cohort patients are through 6 months.

Key facts

Study ID

NCT03973866

Run by

Sequana Medical N.V.

People needed

110

Starts

2019-09-16

Expected to finish

2024-06-30

Last updated by the study team

2022-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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

You may not qualify if…

• At the time of Initial Screening:
• Renal failure defined as serum creatinine higher than 1.5 mg/dL
• More than one episode of spontaneous bacterial peritonitis over the previous 6 months
• More than one episode of bacterascites 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
• BMI>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 > 20
• 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, variceal bleeding within the previous 6 weeks, skin infections or skin ulcers of the anterior abdominal wall within 2 weeks of device placement)
• Hepatocellular carcinoma exceeding Milan criteria or for which RF ablation is anticipated
• ICU admission since enrollment in the 30 days preceding pump implant procedure
• INR >/= 2.0

Where it is running

• Mayo Clinic (Arizona) — Phoenix, Arizona, United States
• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Duke University — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Avera Medical Group — Sioux Falls, South Dakota, United States
• Methodist Dallas — Dallas, Texas, United States
• Baylor University Medical Center (Dallas) — Dallas, Texas, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• Medical College of Wisconsin (Froedtert) — Milwaukee, Wisconsin, United States
• Ottawa Hospital — Ottawa, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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