Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02779400
Brief 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.
Study:
NCT02779400
Study Brief:
Protocol Section:
NCT02779400