NCT04778553

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 26, 2021

Last Update Submit

February 26, 2021

Conditions

Hematologic Tests

Keywords

CBC, WBC, Hemoglobin

Outcome Measures

Primary Outcomes (1)

  • Method Comparison of CBC Results

    Blood Diagnostic Tests for CBC

    October- December 2020

Interventions

iMOST X-1 Hematology AnalyzerDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the hospital outpatient clinic who had voluntarily consented to blood donation for venous and capillary blood collection

You may qualify if:

  • all clinic attendees

You may not qualify if:

  • unable to provide a venous and fingerstick blood specimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Study Officials

  • Megha Shah, M.D.

    Hunterdon Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 3, 2021

Study Start

October 19, 2020

Primary Completion

December 9, 2020

Study Completion

January 21, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

US(1)