The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.
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. All patients have been enrolled in the study and implanted with the alfapump®. Pivotal Cohort patients entered into a 3-month pre-implant observation period in which they received standard of care therapy (consisting of paracentesis) before the alfapump® was implanted. Of the 71 patients enrolled in the Pivotal Cohort, 40 patients have been implanted with the alfapump®. The study allowed for additional patients to be enrolled in a Roll-In Cohort, to ensure centres were experienced with the alfapump® implantation prior to enrolment in the Pivotal Cohort. Finally, 29 patients from the Roll-In Cohort have been implanted with the alfapump®.
Pivotal patients completing the six-months post-implantation period will be included in the primary efficacy endpoint analysis. As well as patients from the Pivotal Cohort and as from the Roll-In Cohort will be included in the overall safety analysis.
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).
ARIA pump STUDY
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.
RETROSPECTIVE MALIGNANT ASCITES STUDY
Retrospective, multi-centre, open-label study in Europe to assess the performance and safety of the alfapump® in 17 patients with malignant ascites (NCT03200106).
MOSAIC IDE FEASIBILITY STUDY
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).
Retrospective, single-centre study at Hannover Medical School to investigate the alfapump® as an alternative for LVP in 21 patients with liver refractory ascites with a contraindication for TIPS or liver transplant.
Prospective, multi-centre, open-label, observational study in Europe designed to follow 100 patients with liver refractory ascites with a contra-indication to TIPS and therefore treated with an alfapump® for up to 24 months (NCT01532427).
Stirnimann et al., Liver International, 2022 (data from 106 patients)
Stirnimann et al., Alimentary Pharmacology & Therapeutics, 2017 (data from first 56 patients)
Editorial by Macdonald and Jalan, Alimentary Pharmacology & Therapeutics, 2017
Prospective, multi-centre, open-label, randomised and controlled study in Europe of the alfapump® versus LVP standard of care in 58 patients with liver refractory ascites (NCT01528410).
Prospective, multi-centre, open-label, uncontrolled study in Europe to assess the safety and performance of the alfapump® in 40 patients with liver refractory ascites and diuretic resistance (NCT01030185).
Consensus care recommendations for alfapump® in cirrhotic patients with refractory or recurrent ascites
Surgical technique for placement of the automated low flow ascites pump (alfapump®)
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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