NCT03071510已完成不适用
IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
Binx Health Limited10 个研究点 分布在 1 个国家目标入组 7,128 人开始时间: 2017年5月18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
- 7,128
- 试验地点
- 10
- 主要终点
- Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
研究概览
简要总结
Atlas Genetics io® system results are compared with those obtained from comparator devices.
详细描述
Results from the Atlas Genetics io® system are compared with a Composite Infection Status obtained from testing on three commonly used comparator devices.
This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of CT/NG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic and asymptomatic individuals ≥14 years of age
排除标准
- •Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
- •Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
结局指标
主要结局
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
时间窗: Up to 7 days
The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices
次要结局
未报告次要终点
研究者
研究点 (10)
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