Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Diagnostic performance
研究概览
简要总结
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
详细描述
During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).
One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.
The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
- •Age >= 18y
排除标准
- •Age < 18y
- •Not eligible to sign an informed consent
- •Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.
- •During menstruation
结局指标
主要结局
Diagnostic performance
时间窗: 12 months
Specificity and sensitivity of the device performance in regard to vaginitis conditions
次要结局
未报告次要终点