Clinical Evaluation of Visby Medical Men's Sexual Health Test
ConditionSexually Transmitted Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age14+
SponsorVisby Medical
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Visby Medical Men's STI PCR Test Kit
Diagnostic testThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov