Clinical Evaluation of Visby Medical Men's Sexual Health Test

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Visby Medical
Study ID
NCT07659808
Status
Completed

Conditions

  • Sexually Transmitted Diseases

Eligibility Criteria

Sex
MALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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 Dates

First listed
Jun 22, 2026
Start date
Feb 5, 2026
Status verified
Aug 2026
Primary completion
Jul 21, 2026
Completion
Jul 21, 2026

Study Design

Enrollment
507 participants (actual)

Primary Outcome Measure

Primary Objective [ Time Frame: up to 12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
AHF Wellness Center - BrowardFort LauderdaleFlorida33316-
Healthcare Clinical Data Inc.Miami LakesFlorida33016-
AHF Wellness Center - PeachtreeAtlantaGeorgia30309-
CrescentCare Sexual Health CenterNew OrleansLouisiana70119-
University of Washington, Virology Research ClinicSeattleWashington98104-

Find similar trials in Fort Lauderdale, FL

By research site
AHF Wellness Center - Broward· Fort Lauderdale, FLHealthcare Clinical Data Inc.· Miami Lakes, FLAHF Wellness Center - Peachtree· Atlanta, GACrescentCare Sexual Health Center· New Orleans, LAUniversity of Washington, Virology Research Clinic· Seattle, WA

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