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Evaluating LumiraDx INR Test Accuracy in Patients Taking Phenprocoumon Anticoagulant.
Sponsor: LumiraDx UK Limited
Summary
This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method). Performance will be demonstrated across a subject population of adult males and females in receipt of Phenprocoumon VKA therapy. This population is representative of the indications for use of the CE marked product. Operators will be trained clinical site staff. Venous plasma and capillary whole blood samples will be obtained from each subject in order to assess accuracy of the the LumiraDx Platform when compared to the reference devices (ACL Elite and Coaguchek Pro).
Official title: Post CE Study: Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
102
Start Date
2019-05-09
Completion Date
2019-09-15
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
Venous and Fingerstick blood draws
Fingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects
Venous blood draw
Venepuncture to collect blood samples from subjects
Locations (1)
CLINICAL SITE Klinik am See, Rehabilitation Clinic for Cardiovascular Diseases, Ruedersdorf/Berlin.
Rüdersdorf, Germany