The primary objective of the CORDIAL project is to perform the early clinical validation of a new peritoneal dialysis (PD) device called WEAKID (brand name). 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 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) to demonstrate the safety and performance of the WEAKID system. Initially also a second trial was planned within this project; however, due to significant delays in the delivery of critical components (fluids, fluidic parts and electronic components) due to among others the COVID pandemic and the Ukraine war, withdrawal of a critical supplier and subsequent delays in required final testing, the focus in this project will be on the FIH trial. The subsequent trial will be planned at a later stage.
In addition to the clinical validation, the project includes usability testing, manufacturing and final acceptance tests of the devices, assessing implementation conditions, patient experience and quality of life, and an early health technology assessment.
