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

October 10, 2018 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône Alpes
      • Grenoble, Rhône Alpes, France, 38043
        • Clinical research center of Grenoble university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients treated with vitamin K agonist or healthy volunteers
  • For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
  • No acute disease in the previous month

Exclusion Criteria:

  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of the device perfomance
Device: Self testing INR device
the procedure involves a series of repeated measurements of INR with the studied device
Other Names:
  • In vitro diagnostic device measuring INR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of measurement of the INR with the study device
Time Frame: Just after the blood taken at day 1
The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.
Just after the blood taken at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of measurement of the INR with the study device
Time Frame: Just after the blood taken at day 1
Comparison of 8 INR measurements performed with the device in a range of 15 minutes.
Just after the blood taken at day 1
Reproductibility of measurement of the INR with the study device
Time Frame: Just after the blood taken at day 1
Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device
Just after the blood taken at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2016

Primary Completion (Actual)

April 14, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC/14/54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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