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NCT04778553

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

Completed Last updated 3 March 2021
What this trial tests

trial testing iMOST X-1 Hematology Analyzer in Hematologic Tests in 60 participants. Completed in 21 January 2021.

Timeline
19 October 2020
Primary endpoint
9 December 2020
21 January 2021

Quick facts

Lead sponsorEssenlix Corporation
StatusCompleted
Study typeOBSERVATIONAL
Enrollment60
Start date19 October 2020
Primary completion9 December 2020
Estimated completion21 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Essenlix Corporation

Who can join

18 and older, any sex, with Hematologic Tests. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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