AWAK Technologies and Singapore General Hospital launch a pre-pivotal clinical trial of a wearable peritoneal dialysis device
AWAK Technologies and Singapore General Hospital announce the launch of a pre-pivotal clinical trial with the enrolment of their first subject to study the safety and efficacy of an improved Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.
AWAK PD is a wearable and ultra-portable peritoneal dialysis (PD) system that allows patients with end-stage kidney disease to have dialysis on the go and has been granted ‘Breakthrough Device Designation’ by the US Food and Drug Administration (FDA).
The single site, prospective, single-arm study is a follow-up of its first-in-human study which reported no serious adverse events. The team of SGH researchers is now recruiting subjects to participate in this pre-pivotal clinical trial.