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Nova Max Creatinine and eGFR Meter System

NCT05118074 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2025-03-13

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Creatinine, eGFR

Compare diagnostic tests to reference methods

Sponsors & Collaborators

  • South Florida Research Organization

    collaborator UNKNOWN

  • Charisma Medical and Research Center

    collaborator UNKNOWN

  • Excellence Medical Research

    collaborator UNKNOWN

  • Nova Biomedical

    lead INDUSTRY

Principal Investigators

  • Giralt Yanez · South Florida Research Organization

  • Eduardo Alvarez · Charisma Medical and Research Center

  • Jeremy Bleicher · Excellence Medical Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2024-04-15
Completion
2024-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118074 on ClinicalTrials.gov