Clinical Evaluation of Visby Medical Men's Sexual Health Test
Running, not enrolling
Conditions studied: Sexually Transmitted Diseases
In brief
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 facts
- Study ID
- NCT07659808
- Run by
- Visby Medical
- People needed
- 1000
- Starts
- 2026-02-05
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 14 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Washington, Virology Research Clinic — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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