At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States
U.S. Army Medical Research and Development Command·observational·Posted May 30, 2013·Updated Feb 25, 2026
In Brief
An observational study for Skin Diseases. Completed, enrolled 150 participants across 1 site.
Detailed Summary
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Diseases
CountriesUnited States
CollaboratorsInBios International, Inc.
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionAug 2013
Study CompletionApr 2014
TodayJul 2026
First PostedMay 30, 2013
Enrollment StartJun 1, 2013
Primary CompletionAug 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.1 years ago