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临床试验/NCT03585049
NCT03585049已完成不适用

Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahinoam Lev-Sagie

Principal Investigator

Meir Medical Center

研究点 (1)

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