NCT07659808已完成不适用
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
Visby Medical6 个研究点 分布在 1 个国家目标入组 507 人开始时间: 2026年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 507
- 试验地点
- 6
- 主要终点
- Primary Objective
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Objective
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (6)
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