At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,295 enrolled
Drug / intervention
Vela Sentosa SA HSV1/2 Qualitative PCR Testdevice
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.
Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
In Brief
An observational study evaluating Vela Sentosa SA HSV1/2 Qualitative PCR Test for Herpes Simplex. Completed, enrolled 2,295 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Simplex
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartApr 2016
Primary CompletionApr 2017
TodayJul 2026
First PostedFeb 19, 2016
Enrollment StartApr 1, 2016
Primary CompletionApr 7, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.4 years ago
Interventions
Vela Sentosa SA HSV1/2 Qualitative PCR Testdevice
medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test