Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT01865032|
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : September 8, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||April 2014|
Skin ulcers. No intervention. Subjects will be followed up by their respective primary providers.
- Specificity [ Time Frame: 1 hour ]Specificity will be presented for the CL Detect™ Rapid Test device against the reference method (microscopy). Specificity will be calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives times 100%.
- False positive rate [ Time Frame: 1 hour ]α, type 1 error, calculated as 1-specificity times 100%
- False negative rate [ Time Frame: 1 hour ]β, type 2 error, calculated as 1-sensitivity times 100%
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865032
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Mark Lebwohl, MD||Icahn School of Medicine at Mount Sinai|