Retrospective, multi-centre, open-label study in Europe to assess the performance and safety of the alfapump® in 17 patients with malignant ascites (NCT03200106).
Prospective, multi-centre, open-label, single-arm study in North America to assess the safety and efficacy of the alfapump® in 30 patients with liver recurrent or refractory ascites not eligible for TIPS (NCT02400164).
This is a single-arm, open-label, within subject crossover study of the alfapump® in patients with recurrent or refractory ascites due to liver cirrhosis in centres across the U.S. and Canada. Up to 60 patients will be enrolled in the study, entering into the pre-implant observation period, allowing for up to 50 patients to be implanted with the alfapump® for primary endpoint analysis. The study also allows for up to 30 patients to be enrolled in a training cohort, to ensure centres are experienced with the alfapump® prior to enrolment in the pivotal study cohort.
Pivotal cohort patients will enter into a 3-month pre-implant observation period in which they will receive standard of care therapy (consisting of paracentesis) before the alfapump® is implanted. The primary effectiveness outcomes of the study include the proportion of patients with a 50% reduction in the overall average frequency of therapeutic paracentesis per month in the post-implant observation period (month four to month six after implantation) as compared to the pre-implant observation period. The primary safety endpoint is the rate of alfapump® related re-interventions adjudicated by the Clinical Events Committee. Patients will be followed for up to two years for analysis of secondary outcome measurements including safety (device and/or procedure-related adverse events), quality of life (assessed by general SF-36 as well as disease-specific Ascites-Q questionnaires), patients’ nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).
This is a prospective, multi-centre, open-label, randomised, health-economic study in France to evaluate the cost utility of the alfapump® versus standard of care in 90 patients with liver refractory ascites, 60 patients not waiting for liver transplant and 30 patients as bridge to transplant, over 12 months. The goal of the study is to support French reimbursement. The study is funded by the French government and being conducted and sponsored by leading French clinicians (NCT03506893).
This is a European registry to collect data from prospectively enrolled patients that have been implanted with the alfapump® across commerical centres in Europe. The registry is supported by key opinion leaders and will assess the adverse event profile of the alfapump® following the technical improvements in product design and care protocols, as well as the effectiveness in real world circumstances. Patients are being enrolled on a continual basis and interim readouts will take place at regular time points.
Case study of treatment of a patient with malignant ascites using the alfapump®.
Review of the available data about patient selection, efficacy and safety of the alfapump® and recommendations for the management of patients treated with the alfapump®.
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