NCT04099199

A Healthcare Economic Study of the Click Sexual Health Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Visby Medical · Industry
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter study with a minimum of three CLIA-Waived intended operator sites in which prospectively collected vaginal swab specimens will be evaluated with the Click Sexual Health Test as compared to standard of care. The specimen collection will occur over one study visit for each enrolled subject, but study staff will continue to follow the subject through standard of care until the subject receives treatment or she is lost to follow up.

Conditions

• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Click Sexual Health Test	The Click Diagnostics 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: 2019-12-03
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2019-09-23
• Last updated: 2021-12-01

Locations

1 site across 1 country: United States