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Clinical Evaluation of Visby Medical Men's Sexual Health Test

2026年8月12日更新者：Visby Medical

Clinical Evaluation of Visby Medical Men's STI PCR Test for Detection of Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) From Urine in an at Home Setting

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.

研究概览

地位

完全的

条件

性病

干预/治疗

诊断测试：Visby Medical Men's STI PCR Test Kit

研究类型

观察性的

注册 (实际的)

507

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Florida
  - Fort Lauderdale、Florida、美国、33316
    - AHF Wellness Center - Broward
  - Miami Lakes、Florida、美国、33016
    - Healthcare Clinical Data Inc.
- Georgia
  - Atlanta、Georgia、美国、30309
    - AHF Wellness Center - Peachtree
- Louisiana
  - New Orleans、Louisiana、美国、70119
    - CrescentCare Sexual Health Center
- Washington
  - Seattle、Washington、美国、98104
    - University of Washington, Virology Research Clinic

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Primary Objective 大体时间：up to 12 months	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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Visby Medical

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月5日

初级完成 (实际的)

2026年7月21日

研究完成 (实际的)

2026年7月21日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日