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Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement — HEMOPTICS2  

Healthy Clinical Trial

Official title:
Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)

Clinical Trial Summary

The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

Clinical Trial Description

The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.

The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.

The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.

A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02779400
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Completed
Phase N/A
Start date May 23, 2016
Completion date June 1, 2018
View Details
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