Clinical Evaluation of Visby Medical Men's Sexual Health Test
Purpose
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.
Condition
- Sexually Transmitted Diseases
Eligibility
- Eligible Ages
- Over 14 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
University of Washington, Virology Research Clinic
Seattle, Washington 98104
Seattle, Washington 98104
More Details
- Status
- Recruiting
- Sponsor
- Visby Medical