RecruitingNCT07659808

Clinical Evaluation of Visby Medical Men's Sexual Health Test

Clinical Evaluation of Visby Medical Men's STI PCR Test for Detection of Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) From Urine in an at Home Setting

Sponsor

Visby Medical

Enrollment

1,000 participants

Start Date

Feb 5, 2026

Study Type

OBSERVATIONAL

Conditions

Sexually Transmitted Diseases

Summary

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.

Eligibility

Sex: MALEMin Age: 14 Years

Inclusion Criteria5

Willing and able to provide written informed consent and/or assent as required by the reviewing IRB or IEC. Experimental Bill of Rights will also be documented for all study subjects enrolled in applicable states.
≥14 years of age at the time of enrollment.
Subject has a penis at the time of enrollment.
Able to read and understand instructions provided for the study.
Willing and able to follow all study procedures, including performing self-collection of one urine sample, running the sample on a Visby test, and using the Visby App to interpret the test results.

Exclusion Criteria5

Have a medical condition, serious illness, or other circumstance that, in the investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures.
Have consumed oral or intramuscular or intravenous antibiotics, within 48 hours prior to enrollment.
The subject has urinated within the last one (1) hour prior to urine sample collection.
Have an in-dwelling catheter or practices intermittent catheterization for urinary drainage.
Have been previously enrolled in this study.

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Interventions

DIAGNOSTIC_TESTVisby Medical Men's STI PCR Test Kit

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.