Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Creation of microscopy image archive
研究概览
简要总结
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions
详细描述
During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.
In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.
No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.
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
- •Vulvovaginal complaints
排除标准
- •Younger than 18y or cannot sign an informed consent form
结局指标
主要结局
Creation of microscopy image archive
时间窗: 1 year
Collecting 1000 images
次要结局
未报告次要终点
研究者
Ahinoam Lev-Sagie
Principal Investigator
Meir Medical Center
