Trials / Recruiting
RecruitingNCT06749223
AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Radiometer Medical ApS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.
Detailed description
The objective is to evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of VTE in patients presenting with low or moderate pretest probability (PTP), by determining the clinical sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the assay.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | D-dimer test | Blood sample collection for D-dimer testing |
Timeline
- Start date
- 2022-04-04
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2024-12-27
- Last updated
- 2025-02-17
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06749223. Inclusion in this directory is not an endorsement.