NCT04098900

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: Visby Medical · Industry
• Sex: Female
• Age: 14 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-09-16
• Primary completion: 2019-12-03
• Completion: 2019-12-03
• First posted: 2019-09-23
• Last updated: 2020-02-17

Locations

5 sites across 1 country: United States