Nova Max Creatinine and eGFR Meter System

Sponsor

Nova Biomedical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05118074

Collaborator

South Florida Research Organization (Other), Charisma Medical and Research Center (Other), Excellence Medical Research (Other)

360

Enrollment

Locations

7.3

Anticipated Duration (Months)

120

Patients Per Site

16.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Acute Kidney Injury	Diagnostic Test: Creatinine, eGFR

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

360 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Nova Max Creatinine and eGFR Meter System - Evaluation

Actual Study Start Date :

Jun 8, 2021

Anticipated Primary Completion Date :

Jan 15, 2022

Anticipated Study Completion Date :

Jan 15, 2022

Outcome Measures

Primary Outcome Measures

Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison [20 days]
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
Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison [20 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Florida Research Organization	Medley	Florida	United States	33166
2	Excellence Medical Research	Miami Gardens	Florida	United States	33169
3	Charisma Medical and Research Center	Miami Lakes	Florida	United States	33014