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Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women

NCT04098900 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 309

Last updated 2020-02-17

No results posted yet for this study

Summary

This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.

Conditions

  • Chlamydial Infection
  • Gonococcal Infection
  • Trichomoniasis

Interventions

DIAGNOSTIC_TEST

Click Sexual Health Test

The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.

Sponsors & Collaborators

  • Visby Medical

    lead INDUSTRY

Eligibility

Min Age
14 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2019-12-03
Completion
2019-12-03

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 NCT04098900 on ClinicalTrials.gov