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

Healthy Clinical Trial

— HEMOPTICS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779400
• Other study ID #: DCIC/14/54
• Status: Completed
• Phase: N/A
• Start date: May 23, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 1, 2018
• Est. primary completion date: April 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Healthy
• Heart Valves
• Thromboembolism

Intervention

Device:
• Self testing INR device
the procedure involves a series of repeated measurements of INR with the studied device

Locations

Country	Name	City	State
France	Clinical research center of Grenoble university hospital	Grenoble	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of measurement of the INR with the study device	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	Repeatability of measurement of the INR with the study device	Comparison of 8 INR measurements performed with the device in a range of 15 minutes.	Just after the blood taken at day 1
Secondary	Reproductibility of measurement of the INR with the study device	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