Nova Max Creatinine and eGFR Meter System

Acute Kidney Injury Clinical Trial

Official title:

Nova Max Creatinine and eGFR Meter System - Evaluation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05118074
• Other study ID #: NB21-eGFR-NA-FDA
• Status: Suspended
• Start date: June 8, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: April 2024
• Source: Nova Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is designed to evaluate the performance of the NM Meter when used by CLIAW operators in terms of both accuracy to an established reference method and precision. CLIAW operators will receive no training or prompting on how to use the NM Creatinine and eGFR Meter, operating only using the instructions found in printed labeling materials (IFU, QRG, packaging). In determining the accuracy of the device, subjects will be tested using the NM Creatinine and eGFR Meter alongside a central laboratory reference method and the results will be compared to one another. This portion of the study is referred to as Method Comparison. In determining the precision of the device, multiple creatinine determinations will be made with the NM Creatinine and eGFR meter using both stabilized control materials (testing over the course of 20 days) and venous whole blood specimens (tested over the course of a single day). The difference between the multiple test results will determine the device's level of precision. This portion of the study is referred to as Precision.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 360
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult males or females (= 18 years of age)

2. CKD Stage 1 (healthy)

3. CKD Stages 2-4

4. Subjects willing and able to consent to participating in the study.

5. Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.

Exclusion Criteria:

1. Subjects unable to consent to participating in the study.

2. 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Creatinine, eGFR
Compare diagnostic tests to reference methods

Locations

Country	Name	City	State
United States	South Florida Research Organization	Medley	Florida
United States	Excellence Medical Research	Miami Gardens	Florida
United States	Charisma Medical and Research Center	Miami Lakes	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Nova Biomedical	Charisma Medical and Research Center, Excellence Medical Research, South Florida Research Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison	Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL	20 days
Primary	Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison	Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for eGFR blood results in mL/min/1.73 m^2	20 days