Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-06 @ 1:35 PM
Study NCT ID:
NCT02779400
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2015-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMOPTICS2
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: