Cel The project aims to validate a miniature wearable dialysis machine in a clinical setting and to prepare the system for CE-marking. Wearable dialysis allows renal patients to dialyze conveniently and continuously at home or at work, independently from a fixed water supply, up to 24 hrs/day. Such a continuous treatment mimics healthy kidneys and is twice as effective as current dialysis techniques, hereby offering health benefits, quality of life (fitness, mobility) while reducing medical costs (less medication, dialysis at home lowers costs). The miniature wearable dialysis system is based on continuous flow peritoneal dialysis with a fluidic access to the abdomen. The peritoneal dialysate is continuously circulated and refreshed by means of a small and wearable sorption unit that removes toxins from the dialysate. The technology has been demonstrated in preclinial research. In order to demonstrate the clinical efficacy and safety of the system an early feasibility first-in- human trial (phase 0) and a pilot crossover trial (phase 1) will be performed in peritoneal dialysis (PD) patients. The phase 0 study will involve a selected group of 12 stable PD patients in a clinical setting for 5 consecutive days. Upon successful functionality and safety analysis of the phase 0 trial, the clinical validation is continued in a crossover study to test the hypotheses that the system (1) improves blood purification, (2) results in adequate ultrafiltration and (3) does not show important safety/ biocompatibility problems. Hereto 30 stable PD patients will be randomised to receive either with the wearable system in the first month and conventional PD in the second month or vice versa. The clinical trials will be performed by three European medical centres specialised in dialysis treatment. Dziedzina nauki medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health scienceshealth sciencesnutritionengineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsmedical and health sciencesmedical biotechnologyimplantsmedical and health sciencesclinical medicinenephrologyrenal dialysis Program(-y) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Temat(-y) SC1-PM-09-2016 - New therapies for chronic diseases Zaproszenie do składania wniosków H2020-SC1-2016-2017 Zobacz inne projekty w ramach tego zaproszenia Szczegółowe działanie H2020-SC1-2016-RTD System finansowania RIA - Research and Innovation action Koordynator UNIVERSITAIR MEDISCH CENTRUM UTRECHT Wkład UE netto € 1 168 125,00 Adres HEIDELBERGLAAN 100 3584 CX Utrecht Niderlandy Zobacz na mapie Region West-Nederland Utrecht Utrecht Rodzaj działalności Higher or Secondary Education Establishments Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 1 168 125,00 Uczestnicy (3) Sortuj alfabetycznie Sortuj według wkładu UE netto Rozwiń wszystko Zwiń wszystko UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA Włochy Wkład UE netto € 597 250,00 Adres VIA UNIVERSITA 4 41121 Modena Zobacz na mapie Region Nord-Est Emilia-Romagna Modena Rodzaj działalności Higher or Secondary Education Establishments Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 597 250,00 NANODIALYSIS BV Niderlandy Wkład UE netto € 984 750,00 Adres De Korenaar 83 5688RX Oirschot Zobacz na mapie MŚP Organizacja określiła się jako MŚP (firma z sektora małych i średnich przedsiębiorstw) w czasie podpisania umowy o grant. Tak Region Zuid-Nederland Noord-Brabant Zuidoost-Noord-Brabant Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Linki Kontakt z organizacją Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 984 750,00 SERVICIO MADRILENO DE SALUD Hiszpania Wkład UE netto € 556 625,00 Adres Paseo De la Castellana, 280 28046 MADRID Zobacz na mapie Region Comunidad de Madrid Comunidad de Madrid Madrid Rodzaj działalności Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 556 625,00
