Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
NCT ID: NCT02779400
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2016-05-23
2018-06-01
Brief Summary
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Detailed Description
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The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.
The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.
A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Evaluation of the device perfomance
Self testing INR device
the procedure involves a series of repeated measurements of INR with the studied device
Interventions
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Self testing INR device
the procedure involves a series of repeated measurements of INR with the studied device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
* No acute disease in the previous month
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Clinical research center of Grenoble university hospital
Grenoble, Auvergne-Rhône-Alpes, France
Countries
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Other Identifiers
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DCIC/14/54
Identifier Type: -
Identifier Source: org_study_id
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