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Not listed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT03074266

Public ClinicalTrials.gov record NCT03074266. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 8:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03074266
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
Accriva Diagnostics
Industry
Enrollment
140 participants

Conditions and interventions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 8, 2017 (Actual)
Primary completion
Dec 2018 (Estimated)
Completion
Dec 2018 (Estimated)
Last update posted
Jul 26, 2018

2017 – 2018

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Accriva Study Site Los Angeles California 90033 —
Accriva Study Site Sacramento California 95816 —
Accriva Study Site Aurora Colorado 80045 —
Accriva Study Site Baltimore Maryland 21215 —
Accriva Study Site Takoma Park Maryland 20912 —
Accriva Study Site New Brunswick New Jersey 08903 —
Accriva Study Site Chapel Hill North Carolina 27514 —
Accriva Study Site Falls Church Virginia 22042 —
Accriva Study Site Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03074266, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 26, 2018 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03074266 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →