Skip to main content
OpenTrials
Completed

NCT Number: NCT02843958

Validation of a Portable Medical Device for Diagnostic in Vitro

This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer Patients Under Vitamin K Antagonist (VKA)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

of healthy volunteers:

  • Man or woman between 18 and 70 years
  • Body Mass Index >18 and <29
  • Absence of any acute pathology in the month preceding the study
  • To be affiliated or beneficiary of social security

Exclusion criteria

of healthy volunteers:

  • Pregnant, partutient or breastfeeding woman
  • Patient with Raynaud's syndrome
  • Person deprived of liberty by legal or administrative decision, person to a legal protection order
  • Deferral periods for other clinical studies
  • Annual threshold compensation attain for biomedical search participations

Inclusion criteria

of patients:

  • Man or woman between 18 and 80 years
  • Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
  • Absence of any acute pathology in the month preceding the study
  • To be affiliated or beneficiary of social security

Exclusion criteria

of healthy patients:

  • Pregnant, partutient or breastfeeding woman
  • Patient with Raynaud's syndrome
  • Person deprived of liberty by legal or administrative decision, person to a legal protection order
  • Deferral periods for other clinical studies
  • Annual threshold compensation attain for biomedical search participations

Treatment and study plan

HEMOPTIC

Device

Primary outcomes

  1. International Normalized Ratio measurement: comparison to the standard reference.

    Time frame: V2

Secondary outcomes

  1. International Normalized Ratio measurement: repeatability

    Time frame: V2

  2. International Normalized Ratio measurement:reproductibility

    Time frame: V2

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters

Acronym: HEMOPTIC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.