CLINICAL RESEARCH

Ongoing studies
Published & Presented studies
Other alfapump publications
Liver and malignant ascites
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).

Liver and malignant ascites
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).

Abstract | Poster by Fotopoulou et al., IGCS, 2018


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).

Abstract | Poster by Wong et al., AASLD, 2017


HANNOVER STUDY
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.

Solbach et al., European Journal of Gasteroenterology & Hepatology, 2018


PMSR
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., Alimentary Pharmacology & Therapeutics, 2017 (data on the first 56 patients)
Editorial by Macdonald and Jalan, Alimentary Pharmacology & Therapeutics, 2017


RCT
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).

Bureau et al., Journal of Hepatology, 2017
Stepanova et al., Quality of Life Research, 2017


PIONEER STUDY
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).

Bellot et al., Journal of Hepatology, 2013

Volume overload due to heart failure
DSR PROOF OF CONCEPT STUDY

Single dose, single arm preclinical proof of concept study to assess impact of direct sodium removal therapy in 15 healthy pigs and 5 pigs with experimentally induced heart failure via tamponade.

Poster by Testani et al., HFSA, 2018

Case study of treatment of a patient with malignant ascites using the alfapump®.

Storni et al., The American Journal of Gastroenterology, 2018


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®.

Stirnimann et al., Therapeutics Advances in Gastroenterology, 2017

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