Yayınlar & Klinik çalışmalar
The ‘Automated Low Flow Pump System for the treatment of Refractory Ascites: a multi-center safety and efficacy study’ (called the PIONEER Study), was a prospective, multi-centre, non-randomised study of patients with refractory ascites due to liver cirrhosis. The Principal Investigator of the PIONEER Study was Dr. Jose Such, Chief of Hepatology at the Hospital General, University de Alicante, Spain. The study was conducted at nine centres in four European countries.
In the PIONEER clinical study, the alfapump system significantly reduced the median number of paracentesis from 3.4 in the month prior to implant to 0.2 per month afterwards - in other words, from once every 9 days to once every 127 days. And many patients required no further paracentesis at all.
Bu çalışma Journal of Hepatology Mayıs 2013 baskısında yayınlandı. Buradan online olarak erişebilirsiniz.
Sürmekte Olan Çalışmalar
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.