NCT02566447|CompletedFDA Device
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Sponsor study identifier
observational
750
1 country
4
Study Start
October 15, 2015
Actual (reported)Primary Completion
August 15, 2016
Actual (reported)Study Completion
August 15, 2016
Actual (reported)The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2015
Actual (reported)October 2, 2015
Actual (reported)October 15, 2015
Actual (reported)August 15, 2016
Actual (reported)August 15, 2016
Actual (reported)Trichomonas Test Result
Testing results will be received by testing site for current FDA cleared tests
2 days
Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.
Specimen collection of urine and/or vaginal swabs for testing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Female subjects symptomatic for Trichomonas vaginalis infection.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
University of North Carolina, Div. of Infectious Diseases
Chapel Hill, North Carolina, 27599-7030, United States
University of Washington in Seattle
Seattle, Washington, 98104, United States
Trichomonas vaginalis in vaginal swabs and urine samples
750 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2015
First Posted
October 2, 2015
Study Start
October 15, 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 15, 2016
Actual (reported)Study Completion
August 15, 2016
Actual (reported)Last Updated
March 20, 2018
Record last verified: 2017-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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