NCT05118074Completed
Nova Max Creatinine and eGFR Meter System
Nova Max Creatinine and eGFR Meter System - Evaluation
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 360 (actual)
- First submitted
- 28 Jul 2021
- Start date
- 8 Jun 2021
- Primary completion date
- 15 Apr 2024
- Lead sponsor
- Nova Biomedical
- Diseases
- Chronic kidney disease
- NCT number
- NCT05118074
What you commit to
- Study type: Observational
- Participants enrolled: 360
- From 8 Jun 2021 to the primary completion date, 15 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Subjects unable to consent to participating in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Florida Research Organization Coordinator of this site? Confirm its status | Medley | United States | Unknown status |
| Excellence Medical Research Coordinator of this site? Confirm its status | Miami Gardens | United States | Unknown status |
| Charisma Medical and Research Center Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.