NCT02779400

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy
• Heart Valves
• Arrhythmias, Cardiac
• Thromboembolism

Interventions

Type	Name	Description
DEVICE	Self testing INR device	the procedure involves a series of repeated measurements of INR with the studied device

Timeline

• Start date: 2016-05-23
• Primary completion: 2018-04-14
• Completion: 2018-06-01
• First posted: 2016-05-20
• Last updated: 2018-10-15

Locations

1 site across 1 country: France