Inflammation Clinical Trial
— NOVEL-2Official title:
Collection of Venous and Capillary Blood Samples for the Research, Optimisation and Calibration of New Diagnostic Devices 2
To research and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that are comparable to the approved gold standard reference methods and will radically enhance clinicians and patients ability to monitor health conditions and improve outcomes by delivering the results near patient at the point of care.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | August 20, 2026 |
Est. primary completion date | August 20, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Subject 18 years of age. - Willing and able to provide written informed consent and comply with study procedures. - Patients attending a definitive care team with research capabilities which has been enroled in this collection study. - Patients who can read and understand written English. - The subject must present as one of the following cohorts: 1. Group A - Embolism Cohort - Patients presenting with symptoms indicative of thromboembolic events. 2. Group B - Infection or Inflammation Cohort - Patients presenting with symptoms indicative of infection or inflammatory disorders. 3. Group C - Cardiovascular Cohort - Patients presenting with symptoms indicative of heart failure or acute coronary syndrome. 4. Group D - Renal Cohort - Patients presenting with symptoms indicative of renal disorders. 5. Group E - Other Cohort. - Patients who are not eligible for any of the above groups. Exclusion Criteria - Subject <18 years of age. - Vulnerable populations deemed inappropriate for the study by the sites Principal Investigator. - Patients who have previously been enroled in any LumiraDx NOVEL study in the past 3 months and re-entry would breach the 24mL and or 6 fingersitck maximums. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Monklands | Airdrie | Scotland |
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
United Kingdom | St John's Hospital | Edinburgh | Scotland |
United Kingdom | Glasgow Royal Infirmary | Glasgow | Scotland |
United Kingdom | Golden Jubilee National Hospital | Glasgow | Scotland |
United Kingdom | Queen Elizabeth University Hospital | Glasgow | Scotland |
United Kingdom | Royal Alexandra Hospital | Paisley | Scotland |
Lead Sponsor | Collaborator |
---|---|
LumiraDx UK Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of blood samples from patients with infection, cardiovascular disease, embolism or renal disease in a reference method and in a novel LumiraDx method. | Measurement of blood samples in a reference method and in a novel LumiraDx method to assess accuracy of the LumiraDx method in patients with infection, cardiovascular disease, embolism or renal disease. Accuracy will be assessed by regression analysis against a reference method. | Up to 5 years | |
Primary | Multiple measurements of blood samples from patients with infection, cardiovascular disease, embolism or renal disease in a novel LumiraDx method. | Multiple measurements of blood samples in a novel LumiraDx method to assess precision of the method in patients with infection, cardiovascular disease, embolism or renal disease. Precision will be assessed by coefficient of variation (%CV) estimates. | Up to 5 years |
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