Validation of a Portable Medical Device for Diagnostic in Vitro

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteer, Patients Under Vitamin K Antagonist (VKA)

Intervention / Treatment
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* Device: HEMOPTIC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers and patients under Vitamin K antagonist<br> | Device: HEMOPTIC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Normalized Ratio measurement: comparison to the standard reference. |  | V2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Normalized Ratio measurement: repeatability |  | V2 | 
| International Normalized Ratio measurement:reproductibility |  | V2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical device, Hemoptic, Vitamin K antagonist, Diagnostic in vitro