Status:
UNKNOWN
Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Lead Sponsor:
Naval Medical Research Center
Conditions:
Leishmaniasis, Cutaneous
Eligibility:
All Genders
18+ years
Brief 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 pa...
Detailed Description
Observational study of a FDA cleared device, the CL Detect™ Rapid Test. Data for the 510(K) was supported by a sensitivity study conducted in Tunisia, Old world Leishamania major and a specificity stu...
Eligibility Criteria
Inclusion
- At least 18 years of age and generally healthy.
- Able to provide written informed consent.
- Index lesion present that is suspicious for CL, as defined by the following criteria for an index lesion:
- less than 2 months in age
- primarily ulcerative, i.e. not purely verrucous or nodular
- no clear clinical evidence of cellulitis
- location suitable for collecting samples by dental broach and scraping.
- Capable of understanding and complying with the protocol, in the opinion of the evaluator
Exclusion
- Received treatment for leishmaniasis within the last 2 months prior to evaluation.
- In the opinion of the investigator, evidence of manipulation of the lesion.
Key Trial Info
Start Date :
October 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03762070
Start Date
October 2 2018
End Date
April 1 2019
Last Update
December 3 2018
Active Locations (2)
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1
Universidad Peruana Cayetano Heredia (UPCH)
Lima, Peru
2
U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6)
Puerto Maldonado, Peru