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

NCT01427023 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 532

Last updated 2014-02-06

No results posted yet for this study

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

  • Trichomonas Vaginalis

Interventions

DEVICE

APTIMA Trichomonas vaginalis (ATV) Assay

APTIMA Trichomonas vaginalis (ATV) Assay

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jennifer Reid, PhD · Gen-Probe, Incorporated

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427023 on ClinicalTrials.gov