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Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru

NCT03762070 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-12-03

No results posted yet for this study

Summary

Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of Leishmania species identified in Peru.

Conditions

  • Leishmaniasis, Cutaneous

Interventions

DEVICE

CL Detect™ Rapid Test

Observational study of a FDA cleared device, the CL Detect™ Rapid Test.

Sponsors & Collaborators

  • Naval Medical Research Center

    lead FED

Principal Investigators

  • Max Grogl, Ph.D. · Scientific Director

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2019-03-31
Completion
2019-04-30
FDA Device
Yes

Countries

  • Peru

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 NCT03762070 on ClinicalTrials.gov