Validation of a Portable Medical Device for Diagnostic in Vitro (HEMOPTIC)
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|ClinicalTrials.gov Identifier: NCT02843958|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : September 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer Patients Under Vitamin K Antagonist (VKA)||Device: HEMOPTIC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
|Healthy volunteers and patients under Vitamin K antagonist||
- International Normalized Ratio measurement: comparison to the standard reference. [ Time Frame: V2 ]
- International Normalized Ratio measurement: repeatability [ Time Frame: V2 ]
- International Normalized Ratio measurement:reproductibility [ Time Frame: V2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843958
|La Tronche, France, 38700|
|Principal Investigator:||Jean-Luc Cracowski, Professor||Grenoble Hospital University|