Periodic Reporting for period 1 - CORDIAL (Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration)
Periodo di rendicontazione: 2021-07-01 al 2022-12-31
The WEAKID system is innovative since instead of a stagnant filling of the abdominal cavity with dialysate as in traditional PD, WEAKID continuously circulates and regenerates dialysate using a sorbent system that adsorbs toxins. Hereby, a significant improvement in blood purification (2-3x) can be achieved in comparison to traditional PD while the number of dialysate exchanges can be reduced from 4-6 to 1 per day (less contamination risk). In addition, in traditional PD very high glucose concentrations are used for osmotic fluid removal that damage the peritoneal membrane. The new system slowly releases glucose so very high glucose concentrations are no longer needed, which helps to preserve the function of the peritoneal membrane and is expected to reduce peritonitis risk (inflammation of the membrane). The WEAKID system is an easy to use, portable/wearable machine that allows renal patients to dialyze conveniently at home or at work, independently from a fixed water supply. The system consists of a nighttime device (i.e. the main component of WEAKID treatment) and a daytime device (optional for patients who desire additional clearance).
The CORDIAL project includes the first-in-human (FIH) investigation (several days of WEAKID treatment in the hospital) and a subsequent crossover feasibility/pivotal (CF) investigation (one month of treatment with WEAKID treatment at home followed by standard PD or vice versa) to demonstrate the safety and performance of the WEAKID system.
In addition to the clinical validation, the project includes usability testing, manufacturing and further development of the devices, assessing implementation conditions, patient experience and quality of life, and an early health technology assessment.
Besides the preparations for the FIH investigation, an international dialysis health care landscape analysis was performed based on interviews with stakeholders in six European countries and a thorough literature search, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. In addition, several dissemination activities were initiated (project website, conference presentations).