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Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older

NCT03074266 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2018-07-26

No results posted yet for this study

Summary

This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.

Conditions

  • Blood Coagulation Test

Interventions

DIAGNOSTIC_TEST

GEM Hemochron 100 ACT

Activated Clotting Time

Sponsors & Collaborators

  • Accriva Diagnostics

    lead INDUSTRY

Principal Investigators

  • Marc Rubinstein, MD · Accriva Diagnostics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2018-12-31
Completion
2018-12-31
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 NCT03074266 on ClinicalTrials.gov