MedTrace Logo

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

NCT02779400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-10-15

No results posted yet for this study

Summary

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

Conditions

  • Healthy
  • Heart Valves
  • Arrhythmias, Cardiac
  • Thromboembolism

Interventions

DEVICE

Self testing INR device

the procedure involves a series of repeated measurements of INR with the studied device

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-23
Primary Completion
2018-04-14
Completion
2018-06-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02779400 on ClinicalTrials.gov