Obiettivo 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. Campo scientifico 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 Programma(i) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Argomento(i) SC1-PM-09-2016 - New therapies for chronic diseases Invito a presentare proposte H2020-SC1-2016-2017 Vedi altri progetti per questo bando Bando secondario H2020-SC1-2016-RTD Meccanismo di finanziamento RIA - Research and Innovation action Coordinatore UNIVERSITAIR MEDISCH CENTRUM UTRECHT Contribution nette de l'UE € 1 168 125,00 Indirizzo HEIDELBERGLAAN 100 3584 CX Utrecht Paesi Bassi Mostra sulla mappa Regione West-Nederland Utrecht Utrecht Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 1 168 125,00 Partecipanti (3) Classifica in ordine alfabetico Classifica per Contributo netto dell'UE Espandi tutto Riduci tutto UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA Italia Contribution nette de l'UE € 597 250,00 Indirizzo VIA UNIVERSITA 4 41121 Modena Mostra sulla mappa Regione Nord-Est Emilia-Romagna Modena Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 597 250,00 NANODIALYSIS BV Paesi Bassi Contribution nette de l'UE € 984 750,00 Indirizzo De Korenaar 83 5688RX Oirschot Mostra sulla mappa PMI L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione. Sì Regione Zuid-Nederland Noord-Brabant Zuidoost-Noord-Brabant Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 984 750,00 SERVICIO MADRILENO DE SALUD Spagna Contribution nette de l'UE € 556 625,00 Indirizzo Paseo De la Castellana, 280 28046 MADRID Mostra sulla mappa Regione Comunidad de Madrid Comunidad de Madrid Madrid Tipo di attività Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 556 625,00