NCT05827588Completed
Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
A Prospective, Single-arm Study to Evaluate the Feasibility of Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) in Subjects With End-Stage Kidney Disease
Source: ClinicalTrials.gov · Last updated 31 Jul 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 30 Mar 2023
- Start date
- 31 Mar 2023
- Primary completion date
- 10 Mar 2024
- Lead sponsor
- AWAK Technologies Pte Ltd
- Diseases
- Chronic kidney disease
- NCT number
- NCT05827588
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 31 Mar 2023 to the primary completion date, 10 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
Other illness
- Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
- Subject has an active infection requiring systemic antibiotics or antifungal therapy.
- Active infection of hepatitis B and C, or HIV infection at any time.
Lab values
- Poorly controlled diabetes mellitus as defined by hemoglobin A1c \>9.0% during Screening
Other
- 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
- Subject has a current abdominal hernia.
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.