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NCT04096313 · ClinicalTrials.gov registry record
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
A clinical trial of Diabetes Mellitus and Kidney Diseases, sponsored by Nova Biomedical.
- Completed
- Registry status
- 628
- Enrollment target
- 3
- Study locations
NCT04096313 is a study of Diabetes Mellitus and Kidney Diseases that has completed, run by Nova Biomedical. The registered enrollment target is 628 participants, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT04096313, a study of Diabetes Mellitus and Kidney Diseases, has completed, sponsored by Nova Biomedical.
- COMPLETED
- Registry status
- 628 participants
- Enrollment target
- 3
- Study locations
Study Summary
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST HbA1c, Lipids, UACR
Study Locations (3)
Florida
- Health Awareness, Inc - Jupiter
- South Florida Research Organization - Medley
- Health Awareness, Inc PSL - Port Saint Lucie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2020-03-25 |
| Est. Completion | 2021-12-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04096313
The ClinicalTrials.gov registry entry for NCT04096313 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (66% lower). The listed sponsor is Nova Biomedical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which HbA1c, Lipids, UACR is the first listed.
NCT04096313 reports 3 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04096313 about?
NCT04096313 is a clinical study titled "Evaluation of the Analytical Performance of ALLEGRO™ Instrument". To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use...
What is the current status of trial NCT04096313?
This trial is currently completed. The enrollment target is 628 participants. The study started on 2020-03-25. Estimated completion is 2021-12-15.
What conditions does trial NCT04096313 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Kidney Diseases, Metabolic Disease.
What interventions are being tested in trial NCT04096313?
The interventions under investigation include: HbA1c, Lipids, UACR (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04096313?
This trial is sponsored by Nova Biomedical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04096313 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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