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Clinical validation of miniature wearable dialysis machine

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.

Invito a presentare proposte

H2020-SC1-2016-2017

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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

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Regione
West-Nederland Utrecht Utrecht
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 1 168 125,00

Partecipanti (3)