Validation of a Portable Medical Device for Diagnostic in Vitro

Not Applicable

Completed

• Conditions: Patients Under Vitamin K Antagonist (VKA); Healthy Volunteer
• Interventions: Device: HEMOPTIC

• Registration Number: NCT02843958
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers and patients under Vitamin K antagonist	HEMOPTIC	-

Primary Outcome Measures

Name	Time	Method
International Normalized Ratio measurement: comparison to the standard reference.	V2

Secondary Outcome Measures

Name	Time	Method
International Normalized Ratio measurement:reproductibility	V2
International Normalized Ratio measurement: repeatability	V2

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France