Scientific evidence

Sequana Medical’s team is dedicated to on-going clinical research. In this section you will find information on studies which have been published along with on-going research.

Published Studies

The ‘randomized controlled trial comparing the alfapump® with paracentesis in patients with refractory ascites: Clinical and pathophysiological effects on cardiac, haemodynamic, inflammatory, renal and nutritional parameters’ (RCT Sub-Study) was led by Dr. Danielle Adebayo at Royal Free Hospital, London, UK. The sub-study was presented at EASL 2015 (P0187) and published in the April 2015 edition of the Journal of Hepatology.

The ‘alfapump® for the treatment of refractory ascites in cirrhotic patients study’ was a post marked surveillance registry study (PMSR) and was led by Dr. Guido Stirnimann. The study was conducted at eight centres in four European countries, was presented at EASL 2015 (P0136) and published in the April 2015 edition of the Journal of Hepatology.

The ‘automated Low Flow Pump System for the treatment of Refractory Ascites: a multi-center safety and efficacy study’ (PIONEER Study), was led by Dr. Jose Such. The study was conducted at nine centres in four European countries. The study was published in the May 2013 edition of the Journal of Hepatology.

The ‘safety and efficacy of an automated low flow ascites pump (alfapump®) in cirrhotic patients with refractory ascites study’ was led by Dr. Andrea De Gottardi at Inselspital, Bern, Switzerland. The study was published in the April 2014 edition of the Journal of Hepatology (P523).

The ‘continuous low-flow ascites drainage and sequential non-invasive tumor-cell sampling through the urinary bladder via the alfapump® closed system in platinum-resistant ovarian cancer (PROC): First clinical experience in a cancer patient study’ was a malignant ascites case study, led by Christina Fotopoulou at Imperial College, London, UK. The study was presented at ASCO 2013 (abstr 5562) and published in the Journal of Clinical Oncology 2013.

On-going Studies

A 200 patient post market surveillance registry entitled ‘alfapump® System Post Marketing Surveillance Registry’ (NCT01532427) is being led by Dr Andrea de Gottardi at Inselspital, Bern.

A 60 patient multicentre, open, randomised, and controlled trial entitled ‘alfapump® System Versus Standard of Care in Ascites Treatment’ (NCT01528410) is being led by Professor Rajiv Jalan at the Royal Free Hospital, London.

A 12 patient single centre, prospective, uncontrolled study entitled ‘Effects of Treatment of Ascites by the alfapump® System on Renal and Circulatory Function’ (NCT01438970) is being led by Professor Pere Gines at Hospital Clinic, Barcelona.

‘A multi-center, prospective, open label, uncontrolled feasibility study to assess the safety and effectiveness of an automatic low flow ascites pump in patients with cirrhosis and refractory or recurrent ascites’ (MOSAIC) (NCT02400164) is being led by MD Patrick Kamath at Mayo Clinic, Rochester, MN.

If you wish to carry out a clinical study involving the alfapump® system, please contact us