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Validation of a Portable Medical Device for Diagnostic in Vitro

NCT02843958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-30

No results posted yet for this study

Summary

This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.

Conditions

  • Healthy Volunteer
  • Patients Under Vitamin K Antagonist (VKA)

Interventions

DEVICE

HEMOPTIC

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Luc Cracowski, Professor · Grenoble Hospital University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • France

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 NCT02843958 on ClinicalTrials.gov