Actively Recruiting
Clinical Evaluation of the AQT90 FLEX D-dimer Test for Diagnosing Venous Thromboembolism in Adults with Low or Moderate Risk
Led by Radiometer Medical ApS · Updated on 2025-02-17
600
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of the AQT90 FLEX D-dimer Test to help diagnose Venous Thromboembolism VTE in patients who show signs and symptoms of VTE and have a low or moderate pre-test probability based on the Wells score. The study aims to determine how well the test can detect VTE by measuring its sensitivity, specificity, and predictive values. The study involves collecting blood samples from participants for D-dimer testing using the AQT90 FLEX device. This observational study does not involve any treatment but focuses on assessing the tests diagnostic accuracy within about one hour after enrollment and sample collection. Participants will be assessed for eligibility and provide informed consent before enrollment. Researchers will analyze blood samples to measure the tests sensitivity and specificity in diagnosing VTE. The study includes monitoring participants during the brief evaluation period, with no long-term treatment or follow-up required. Total participation time corresponds to enrollment and quick blood sample collection.
CONDITIONS
Brief Title
AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
Research Team
H
Helle Toftegaard Petersen
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