Nova Max Creatinine and eGFR Meter System

NCT05118074 | Completed FDA Device

• 1 other identifier: NB21-eGFR-NA-FDA
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Kidney Diseases; Acute Kidney Injury

Keywords

eGFR; Creatinine; POCT

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Creatinine, eGFR DIAGNOSTIC_TEST

Compare diagnostic tests to reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be identified via medical records for history of CKD or compromised kidney function and contacted to participate in this study. Study site personnel will provide details regarding the study (requirements, test procedure, subject rights) to obtain informed consent from the subject. Potential subjects will be screened using the protocol inclusion and/or exclusion criteria. Adult subjects (≥ 18 years of age) with creatinine levels spanning the entire AMR of the NM Creatinine and eGFR Meter will be recruited for the study.

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.

Sponsors & Collaborators

• Nova Biomedical: lead
• South Florida Research Organization: collaborator
• Charisma Medical and Research Center: collaborator
• Excellence Medical Research: collaborator

Study Sites (3)

South Florida Research Organization

Medley, Florida, 33166, United States

Location

Excellence Medical Research

Miami Gardens, Florida, 33169, United States

Location

Charisma Medical and Research Center

Miami Lakes, Florida, 33014, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giralt Yanez

  South Florida Research Organization

  PRINCIPAL INVESTIGATOR

• Eduardo Alvarez

  Charisma Medical and Research Center

  PRINCIPAL INVESTIGATOR

• Jeremy Bleicher

  Excellence Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: November 11, 2021
• Study Start: June 8, 2021
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)