The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are: * the success of AWAK PD therapies when used in a home-setting * the safety and effectiveness of the AWAK PD system Participants will: * be titrated to find a suitable AWAK PD prescription * be trained on how to use the AWAK PD system independently * use the AWAK PD system at home for at least 7 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy
Singapore General Hospital
Singapore, Singapore
Proportion of completed therapies
Time frame: 7 days
Proportion of subjects maintaining body weight within ±5% of the subject's target weight
Time frame: 7 days
Change in serum levels of markers of uremia (urea and creatinine)
Time frame: 7 days
Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges
Time frame: 7 days
Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events
Time frame: 7 days
Incidence of peritonitis related to the use of AWAK PD
Time frame: 30 days
Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire
Time frame: 30 days
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