A new clinical trial aims to evaluate the performance of a point-of-care creatinine testing system for individuals with chronic and acute kidney conditions. This investigational study, sponsored by Tingting Xu, will compare a novel creatinine diagnostic device labeled as the EG system against the established Cobas c 111, a reference test.
The trial is registered but not yet recruiting participants as of November 26, 2025, and could offer valuable insights to clinical, quality, and regulatory experts as they monitor advancements in diagnostic technologies.
To help you navigate this article, see the sections below:
- What is this trial about?
- Which conditions will be studied?
- What are the test methods?
- FAQ
- Conclusion
- Disclaimer
- Source and additional details
What is this trial about?
The study investigates the clinical performance of a new point-of-care creatinine measurement device (EG system) designed to aid in diagnosing and managing kidney disease. Clinical trials can provide the evidence base required for regulatory clearance, demonstrating both safety and effectiveness in real-world scenarios.
With chronic kidney disease and acute kidney injury being major public health concerns globally, technologies that deliver timely and accurate diagnostic information could address critical gaps in patient care.
Which conditions will be studied?
The trial will include participants with either chronic kidney disease (CKD) or acute kidney injury (AKI). CKD affects millions worldwide due to long-term damage to kidney function, while AKI is a sudden condition requiring immediate diagnosis and treatment. Both conditions benefit significantly from reliable and fast diagnostic methods.
What are the test methods?
Two diagnostic systems will be compared:
- Reference System: Cobas c 111, an established diagnostic tool for creatinine measurement utilized in clinical laboratories.
- Investigational System: EG system, a point-of-care device under evaluation to assess its accuracy, reliability, and usability in clinical and near-patient settings.
Point-of-care testing systems, by design, expedite the diagnostic process by integrating testing capabilities into patient-side workflows, often reducing delays from sample transport or laboratory processing.
Frequently Asked Questions
- When will the trial start?
The trial is currently listed as “not yet recruiting.” Future updates will confirm the recruitment timeline. - Who can participate?
Eligible candidates are individuals diagnosed with either chronic kidney disease or acute kidney injury. Specific inclusion criteria will be outlined later. - What are the goals of this study?
To determine the accuracy, performance, and potential clinical adoption of the EG point-of-care system compared with the reference Cobas c 111 system. - Where can I access additional details?
The trial is registered under ClinicalTrials.gov with the study ID NCT07251075.
Conclusion
This trial promises to shed light on the capabilities of point-of-care diagnostic tools for creatinine measurement, potentially improving kidney disease management for millions worldwide. Experts in clinical diagnostics and regulatory affairs should monitor its developments closely.
Disclaimer
This article is informational and does not constitute legal or medical advice. Always consult appropriate regulatory guidance and professional expertise for interpretation.
Source and additional details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07251075?term=medical+device