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Clinical validation of miniature wearable dialysis machine

Información del proyecto

Identificador del acuerdo de subvención: 733169

  • Fecha de inicio

    1 Enero 2017

  • Fecha de finalización

    30 Junio 2019

Financiado con arreglo a:

H2020-EU.3.1.3.

  • Presupuesto general:

    € 3 306 750

  • Aportación de la UE

    € 3 306 750

Coordinado por:

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Países Bajos

Objetivo

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.
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Coordinador

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Dirección

Heidelberglaan 100
3584 Cx Utrecht

Países Bajos

Tipo de actividad

Higher or Secondary Education Establishments

Aportación de la UE

€ 1 168 125

Participantes (3)

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA

Italia

Aportación de la UE

€ 597 250

NANODIALYSIS BV

Países Bajos

Aportación de la UE

€ 984 750

SERVICIO MADRILENO DE SALUD

España

Aportación de la UE

€ 556 625

Información del proyecto

Identificador del acuerdo de subvención: 733169

  • Fecha de inicio

    1 Enero 2017

  • Fecha de finalización

    30 Junio 2019

Financiado con arreglo a:

H2020-EU.3.1.3.

  • Presupuesto general:

    € 3 306 750

  • Aportación de la UE

    € 3 306 750

Coordinado por:

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Países Bajos