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Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study

NCT04778553 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-03-03

No results posted yet for this study

Summary

This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

Conditions

  • Hematologic Tests

Interventions

DIAGNOSTIC_TEST

iMOST X-1 Hematology Analyzer

The X-1 is a point of care automated hematology analyzer

Sponsors & Collaborators

  • Essenlix Corporation

    lead INDUSTRY

Principal Investigators

  • Megha Shah, M.D. · Hunterdon Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2020-12-09
Completion
2021-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04778553 on ClinicalTrials.gov