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A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay

NCT04737954 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2022-09-21

No results posted yet for this study

Summary

In patients with symptoms of Venous Thromboembolism (VTE) (mainly deep vein thrombosis (DVT) or pulmonary embolism (PE)), the study will evaluate the agreement between the D-Dimer measurements from the LumiraDx POC D-Dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of DVT and PE.

Conditions

Interventions

DIAGNOSTIC_TEST

Venepuncture

Venous blood draw

DIAGNOSTIC_TEST

Fingerstick

Capillary blood draw

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Richard Body · Professor of Emergency Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2022-06-30
Completion
2022-09-30

Countries

  • Germany
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737954 on ClinicalTrials.gov