Validation of a Portable Medical Device for Diagnostic in Vitro

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02843958

Acronym

HEMOPTIC

Enrollment

Registered

2016-07-26

Start date

2013-06-30

Completion date

2014-02-28

Last updated

2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Patients Under Vitamin K Antagonist (VKA)

Keywords

Medical device, Hemoptic, Vitamin K antagonist, Diagnostic in vitro

Brief summary

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.

Interventions

DEVICEHEMOPTIC

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
International Normalized Ratio measurement: comparison to the standard reference.	V2

Secondary

Measure	Time frame
International Normalized Ratio measurement: repeatability	V2
International Normalized Ratio measurement:reproductibility	V2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026