Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD. (NCT05827588) | Clinical Trial Compass
CompletedNot Applicable
Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
Singapore12 participantsStarted 2023-03-31
Plain-language summary
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
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent to participate in the study.
. Male or female ≥22 years of age.
. Treated with PD for at least 3 months before Screening.
. Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
. No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.
Exclusion criteria
. Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good investigation candidate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a device called AWAK PD for people with end-stage kidney disease — can you explain what peritoneal dialysis via a wearable device like this actually involves day-to-day, and how it compares to my current or planned treatment options?
2The trial is listed as a feasibility study and has already completed — what do those results tell us about whether the AWAK PD device was safe and practical to use, and is that data publicly available for us to review together?
3Since the main thing this study measured was the proportion of completed therapies rather than long-term health outcomes, does that mean we still don't have strong evidence about whether this device improves survival or quality of life compared to standard dialysis?
4Given that this was a feasibility-phase study, meaning it was primarily designed to test whether the device could work rather than prove it's better than existing treatments, should I be considering a more established form of dialysis first while this technology continues to be evaluated?
5Are there any follow-up trials or next steps planned for the AWAK PD device, and is participating in one of those something worth discussing based on my specific kidney disease situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.