Nova Max Creatinine and eGFR Meter System

Completed

Conditions studied: Chronic Kidney Diseases, Acute Kidney Injury

In brief

To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL creatinine determination). To assess the Ease of Use of the Nova Max Creatinine and eGFR Meter System in the hands of the intended CLIA-Waived Point-of-Care users.

Key facts

Study ID

NCT05118074

Run by

Nova Biomedical

People needed

360

Starts

2021-06-08

Expected to finish

2024-04-15

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult males or females (≥ 18 years of age)
• CKD Stage 1 (healthy)
• CKD Stages 2-4
• Subjects willing and able to consent to participating in the study.
• Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.

You may not qualify if…

• Subjects unable to consent to participating in the study.
• Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.

Where it is running

• South Florida Research Organization — Medley, Florida, United States
• Excellence Medical Research — Miami Gardens, Florida, United States
• Charisma Medical and Research Center — Miami Lakes, Florida, United States

Full record on ClinicalTrials.gov

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