Disclaimer
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.
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).
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., 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
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, 2018
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).
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.
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