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Leukocyte Esterase Sensor Test

NCT04390607 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2020-09-23

No results posted yet for this study

Summary

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

Conditions

  • Prosthetic Joint Infection

Interventions

DIAGNOSTIC_TEST

leukocyte esterase electrochemical assay

A sample of blood drawn for routine standard of care laboratory assessments will be used to also test the new electrochemical assay. This is a validation study and the results of the electrochemical assay will not be used to treat patients

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-09-30
Completion
2021-10-31

Countries

  • United States

Study Locations

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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 NCT04390607 on ClinicalTrials.gov