Clinical Evaluation of Visby Medical Men's Sexual Health Test

Visby Medical

Status: Completed

Conditions: Sexually Transmitted Diseases

Treatments: Diagnostic Test: Visby Medical Men's STI PCR Test Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT07659808

TP-400347

Details and patient eligibility

About

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.

Enrollment: 507 patients

Sex: Male

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.