Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters

University Hospital, Grenoble1 site in 1 country40 target enrollmentJune 2013

ConditionsHealthy Volunteer Patients Under Vitamin K Antagonist (VKA)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Volunteer
Sponsor: University Hospital, Grenoble
Enrollment: 40
Locations: 1
Primary Endpoint: International Normalized Ratio measurement: comparison to the standard reference.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

February 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group