Periodic Reporting for period 2 - CORDIAL (Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration)
Okres sprawozdawczy: 2023-01-01 do 2024-06-30
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.
Besides the execution of the FIH trial, work has been done to analyse the economic aspects of the future introduction and use of the device, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. Also a survey has been opened for PD patients, which is accessible via the project’s website. In the meanwhile, the device and work is being demonstrated at various conferences and other events.