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Evaluation of the Analytical Performance of ALLEGRO™ Instrument

NCT04096313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 628

Last updated 2021-12-16

No results posted yet for this 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

Interventions

DIAGNOSTIC_TEST

HbA1c, Lipids, UACR

compare diagnostic tests to reference methods

Sponsors & Collaborators

  • Nova Biomedical

    lead INDUSTRY

Principal Investigators

  • Ronald Surowitz · Health Awareness, Inc

  • Allison Blomer, MA, MD · Health Awareness, Inc PSL

  • Jeremy Bleicher · South Florida Research Organization

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2021-11-11
Completion
2021-12-15
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 NCT04096313 on ClinicalTrials.gov