Clinical Trials Directory

Trials / Completed

CompletedNCT01427023

Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

Status
Completed
Phase
Study type
Observational
Enrollment
532 (actual)
Sponsor
Gen-Probe, Incorporated · Industry
Sex
Female
Age
14 Years
Healthy volunteers
Accepted

Summary

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay. These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Conditions

Interventions

TypeNameDescription
DEVICEAPTIMA Trichomonas vaginalis (ATV) AssayAPTIMA Trichomonas vaginalis (ATV) Assay

Timeline

Start date
2012-08-01
Primary completion
2013-03-01
Completion
2013-12-01
First posted
2011-09-01
Last updated
2014-02-06

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01427023. Inclusion in this directory is not an endorsement.

Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing (NCT01427023) · Clinical Trials Directory