Clinical Evaluation of Visby Medical Men's Sexual Health Test

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.

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Key information

Conditions

Sexually Transmitted Diseases Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

14 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AHF Wellness Center - Broward, Fort Lauderdale, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

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.

Primary outcomes

Primary Objective

Time frame: up to 12 months

Evaluate the performance of the Visby test when run by male subjects ≥ 14 years of age, on self-collected first catch urine sample using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions.

Sponsors and collaborators

Lead sponsor

Visby Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 22, 2026
Registry last updated: Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed