Collecting blood samples to develop new diagnostic devices
Collection of Venous and Capillary Blood Samples for the Research, Optimisation and Calibration of New Diagnostic Devices 2
This study is testing new blood tests to see if they can help doctors and patients better monitor chronic health conditions right at the doctor's office.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LumiraDx UK Limited Industry-sponsored |
| Locations | 7 sites (Airdrie, Scotland and 6 other locations) |
| Trial ID | NCT05568966 on ClinicalTrials.gov |
What this trial studies
This study aims to research and develop new diagnostic biomarkers using the LumiraDx Platform, which will enhance the ability of clinicians and patients to monitor chronic health conditions at the point of care. By collecting blood samples from up to 20,000 patients presenting with various health issues, the study will compare the performance of these new biomarkers against established gold standard methods. The LumiraDx Platform allows for multiple tests to be conducted on a single device, facilitating efficient and effective health monitoring. Participants will provide informed consent and undergo a brief blood draw as part of the study.
Who should consider this trial
Good fit: Ideal candidates include adults presenting with symptoms of embolism, infection, inflammation, cardiovascular issues, or renal disorders.
Not a fit: Patients under 18 years of age or those from vulnerable populations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the monitoring and management of chronic health conditions for patients.
How similar studies have performed: Other studies have shown promise in developing point-of-care diagnostic devices, but this specific approach using the LumiraDx Platform is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Airdrie, Scotland and 6 other locations
- University Hospital Monklands — Airdrie, Scotland, United Kingdom (Recruiting)
- Royal Infirmary of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)
- St John's Hospital — Edinburgh, Scotland, United Kingdom (Recruiting)
- Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom (Recruiting)
- Queen Elizabeth University Hospital — Glasgow, Scotland, United Kingdom (Recruiting)
- Golden Jubilee National Hospital — Glasgow, Scotland, United Kingdom (Recruiting)
- Royal Alexandra Hospital — Paisley, Scotland, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Roy Gardner — NHS National Waiting Times Centre Board
- Study coordinator: David Craig
- Email: novel-2@lumiradx.com
- Phone: 0044 1786 533232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.