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StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

NCT05118048 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2021-11-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

Conditions

Interventions

DIAGNOSTIC_TEST

Lactate, Hemoglobin, Hematocrit

Compare diagnostic tests to reference methods

Sponsors & Collaborators

  • Buffalo General Medical Center

    collaborator UNKNOWN

  • Erie County Medical Center

    collaborator OTHER

  • Millard Fillmore Suburban Hospital

    collaborator UNKNOWN

  • Nova Biomedical

    lead INDUSTRY

Principal Investigators

  • Brooke Lerner, PhD, FAEMS · Buffalo General Medical Center

  • Brooke Lerner, PhD, FAEMS · Erie County Medical Center

  • Brooke Lerner, PhD, FAEMS · Millard Fillmore Suburban Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-10-22
Completion
2021-10-22
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 NCT05118048 on ClinicalTrials.gov