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A Healthcare Economic Study of the Click Sexual Health Test

NCT04099199 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2021-12-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Visby Medical

    lead INDUSTRY

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2021-03-29
Completion
2021-03-29

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 NCT04099199 on ClinicalTrials.gov