Clinical Evaluation of Visby Medical Men's Sexual Health Test

NCT07659808 | Completed

• 1 other identifier: TP-400347
• Study Type: observational
• Target: 507
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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.

  up to 12 months

Interventions

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of subjects with a penis ≥14 years of age who are symptomatic or asymptomatic for sexual transmitted infections (STIs). Subjects will be classified as symptomatic if they report unusual urethral discharge, painful urination, testicular or scrotal pain/swelling, increased urinary frequency, pain or bleeding during sex/intercourse within 7 days prior to enrollment. To better represent the end users of this product, subjects not actively seeking health care will be recruited into the study with the goal that \~30% of subjects would fall in this category.

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.

Sponsors & Collaborators

• Visby Medical: lead

Study Sites (5)

AHF Wellness Center - Broward

Fort Lauderdale, Florida, 33316, United States

Location

Healthcare Clinical Data Inc.

Miami Lakes, Florida, 33016, United States

Location

AHF Wellness Center - Peachtree

Atlanta, Georgia, 30309, United States

Location

CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119, United States

Location

University of Washington, Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: February 5, 2026
• Primary Completion: July 21, 2026
• Study Completion: July 21, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

US (5)