Clinical Evaluation of Visby Medical Men's Sexual Health Test

Part of paid clinical trials in Seattle, Washington.

Sponsor
Visby Medical
Study ID
NCT07659808
Status
Recruiting
Apply to this trial

Conditions

  • Sexually Transmitted Diseases

Eligibility Criteria

Sex
MALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Visby Medical Men's STI PCR Test Kit — DIAGNOSTIC_TEST
    The Visby Medical Men's STI PCR Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. This test is intended to be sold over the counter (OTC) for use by males suspected of sexually transmitted infection with Chlamydia trachomatis and Neisseria gonorrhoeae.

Study Details

This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions.

Key Dates

Start date
Feb 5, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Primary Objective [ Time Frame: up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington, Virology Research ClinicSeattleWashington98104
Kirsten Hauge
[email protected]
206-520-4341

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By research site
University of Washington, Virology Research Clinic· Seattle, WA

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