Nova Max Creatinine and EGFR Meter System

March 10, 2025 updated by: Nova Biomedical

Nova Max Creatinine and EGFR Meter System - Evaluation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Wei Qiu, MD, PhD
  • Phone Number: 1715 781-894-0800
  • Email: wqiu@novabio.com

Study Locations

  • United States
    • Florida
      • Medley, Florida, United States, 33166
        • South Florida Research Organization
      • Miami Gardens, Florida, United States, 33169
        • Excellence Medical Research
      • Miami Lakes, Florida, United States, 33014
        • Charisma Medical and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison
Time Frame: 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
20 days
Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison
Time Frame: 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
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Biomedical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South Florida Research Organization
Charisma Medical and Research Center
Excellence Medical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giralt Yanez, South Florida Research Organization
  • Principal Investigator: Eduardo Alvarez, Charisma Medical and Research Center
  • Principal Investigator: Jeremy Bleicher, Excellence Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB21-eGFR-NA-FDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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