Validation of a Portable Medical Device for Diagnostic in Vitro

Healthy Volunteer Clinical Trial

— HEMOPTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843958
• Other study ID #: 38RC14.008
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: September 29, 2016
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Patients Under Vitamin K Antagonist (VKA)

Intervention

Device:
• HEMOPTIC

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Faivre M, Peltié P, Planat-Chrétien A, Cosnier ML, Cubizolles M, Nougier C, Négrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813. — View Citation

Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367(9508):404-11. Review. — View Citation

Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617. Erratum in: N Engl J Med. 2011 Jan 6;364(1):93. — View Citation

McBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062.

Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Normalized Ratio measurement: comparison to the standard reference.		V2	No
Secondary	International Normalized Ratio measurement: repeatability		V2	No
Secondary	International Normalized Ratio measurement:reproductibility		V2	No