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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

May 23, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

August 27, 2015

Last Update Submit

October 10, 2018

Conditions

HealthyHeart ValvesArrhythmias, CardiacThromboembolism

Keywords

INRcoagulationvitamin K antagonist

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Repeatability of measurement of the INR with the study device

    Just after the blood taken at day 1

  • Reproductibility of measurement of the INR with the study device

    Just after the blood taken at day 1

Study Arms (1)

Evaluation of the device perfomance

EXPERIMENTAL
Device: Self testing INR device

Interventions

Self testing INR deviceDEVICE

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

Also known as: In vitro diagnostic device measuring INR
Evaluation of the device perfomance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical research center of Grenoble university hospital

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

MeSH Terms

Conditions

Arrhythmias, CardiacThromboembolismThrombosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

May 20, 2016

Study Start

May 23, 2016

Primary Completion

April 14, 2018

Study Completion

June 1, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)