NCT07251075Not yet recruiting
Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with non-dialysis-dependent kidney disease. The main questions it aims to answer are: 1. How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method? 2. How usable is the Creatinine Monitoring System for laypersons in a home setting? Researchers will compare creatinine results obtained with the investigational creatinine test system (fingerstick capillary whole blood) to those from a Cobas biochemical analysis system（referred to as Cobas) (venous plasma) to determine whether the investigational device provides accurate and reliable measurements. Participants will: 1. Provide a venous blood sample for comparative testing. 2. Perform self-testing using the Creatinine Monitoring System without prior training. 3. Complete a usability questionnaire about their experience with the investigational creatinine test system.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Tingting Xu
- Diseases
- Chronic kidney disease
- NCT number
- NCT07251075
What you commit to
- Study type: Observational
- Planned participants: 200
- From 30 Nov 2025 to the primary completion date, 30 Dec 2025
- No sites listed in no 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.
Other illness
- Severe mental illness or other conditions that make the patient unable to cooperate;
- Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate.
Lab values
- Previous experience with this creatinine monitoring system or similar self-monitoring devices (including but not limited to those for glucose, ketones, total cholesterol, etc.);
Age
- Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.);
Other
- The HCT range is not within 25-65%;
- Inability to read or write in English language;
Who the study is looking for
- Abnormal creatinine levels or suspected kidney disease;
- Aged 18 and above, gender is not limited;
- Voluntarily participate in this clinical study by signing the informed consent form.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.