Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study) (NCT03973866) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
United States110 participantsStarted 2019-09-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. 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
What they're measuring
1
Per-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesis
Timeframe: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period:
2
Proportion of patients with at least 50% reduction in number of therapeutic paracenteses from the pre-observation period to post-observation period
Timeframe: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period
3
Combined rate of open surgical reintervention due to pump system related adverse event or to restore pump functionality, pump explant due to pump system related adverse event, or pump system related death
Timeframe: from time of pump implant through 6 months post-implant
. 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