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Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease

NCT07251075 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Diseases
  • Kidney Injury, Acute

Interventions

DIAGNOSTIC_TEST

Reference Creatinine Test System（Cobas c 111）

This group involves the use of the Cobas biochemical analyzer for measurement of venous plasma creatinine samples. The results obtained from Cobas will be compared with those obtained from the investigational Eaglenos Creatinine Test System to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.

DIAGNOSTIC_TEST

Investigational Creatinine Test System （EG）

This group involves the use of the Eaglenos Creatinine Test System, a handheld device designed for self-testing of fingerstick capillary whole blood by laypersons with non-dialysis-dependent kidney disease. The results obtained from EG will be compared with those obtained from the Cobas biochemical analyzer to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.

Sponsors & Collaborators

  • Tingting Xu

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251075 on ClinicalTrials.gov