Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682419
Other study ID # D-CLIN-PROT-00001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2018
Est. completion date November 23, 2018

Study information

Verified date September 2018
Source LumiraDx UK Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.


Description:

A performance evaluation study designed to assess the precision and accuracy of the LumiraDx Instrument, a point of care in vitro diagnostic system employing a portable diagnostic meter in conjunction with single use analyte test strips, for the quantitative determination of Prothrombin Time expressed as International Normalised Ratio (INR), as sampled from individuals evaluated for INR at the point of care (POC).

The accuracy of the LumiraDx Instrument INR results will be assessed by, in the first instance, comparison to the INR results obtained from the same individuals as analysed by trained laboratory professionals using the paired venous plasma samples in the reference device IL ACL ELITE PRO Coagulation Analyzer. The accuracy of INR measurements of capillary whole blood across the range of haematocrit (25% - 55%) will be assessed using paired haematocrit results obtained from the HemoCue Hb 201+ on venous whole blood. The results of these evaluations are intended to be used for regulatory filings for the LumiraDx Instrument and LumiraDx INR test as an in vitro diagnostic test in the European Union (EU) and other relevant geographies. For information only, the accuracy of the LumiraDx Instrument INR Test will also be assessed by comparison to INR results from an alternative point of care instrument, the Roche Coaguchek PRO II.

Adult males and females currently in receipt of vitamin K antagonist therapy will be included on the study. Approximately 500 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation as well as recommendations of the FDA CLIA Waiver Guidance document (1) requires a minimum of 360 valid subjects in total (inclusive of non-therapy subset). A subsection of the subject population (~50 subjects) will consist of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This will be done in order to test the lower measurement limit of the LumiraDx Instrument INR test. At the end of the study the Healthcare Professional will be asked to complete a User Acceptability Questionnaire which is intended to assess the acceptability of the LumiraDx INR system in terms of ease of use.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date November 23, 2018
Est. primary completion date November 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - VKA Therapy Subjects:

- Persons >18 years of age

- Willing and able to provide written informed consent and comply with study procedures

- Currently prescribed vitamin K antagonist therapy

- Deemed medically appropriate for study participation by the Investigator

Exclusion Criteria - VKA Therapy Subjects:

- Persons <18 years of age

- Subject has previously participated in this study

- Subject is within 4 weeks of first prescription of vitamin K antagonist therapy

- Confirmed or suspected pregnancy

- Unwilling or unable to provide written informed consent and comply with study procedures

- Vulnerable populations deemed inappropriate for study by the Investigator

- Deemed medically inappropriate for study by the Investigator (i.e. patients with a known inherited [e.g. haemophilia or von Willebrand's disease] or acquired [e.g. liver cirrhosis] condition likely to be associated with a coagulopathy; or patients receiving non-VKA anticoagulant medications)

Inclusion Criteria - Non-VKA Therapy Subjects:

- Persons >18 years of age

- Willing and able to provide written informed consent and comply with study procedures

- Deemed medically appropriate for study participation by the Investigator

Exclusion Criteria - Non-VKA Therapy Subjects:

- Persons <18 years of age

- Subject has previously participated in this study

- Confirmed or suspected pregnancy

- Unwilling or unable to provide written informed consent and comply with study procedures

- Vulnerable populations deemed inappropriate for study by the Investigator

- Any persons deemed medically inappropriate for study by the Investigator

Study Design


Intervention

Procedure:
VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy

Locations

Country Name City State
United Kingdom Glasgow Royal Infirmary Clinical Research Facility Glasgow
United Kingdom Golden Jubilee National Hospital Glasgow
United Kingdom Wishaw General Hospital, NHS Lanarkshire Wishaw

Sponsors (1)

Lead Sponsor Collaborator
LumiraDx UK Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the clinical performance of the LumiraDx instrument Measurement of INR using Capillary & Venous blood samples 8 weeks
Secondary To determine the accuracy of the LumiraDx instrument Measurement of INR & Haematocrit using Capillary & Venous blood samples 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A