Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- Comparison parameter
研究概览
简要总结
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.
Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes.
The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥18 years old
- •Able to read, understand and sign an informed consent form
- •At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.
排除标准
- •Patients under the age of 18 years
- •Patient is unfit to provide an informed consent
- •Patient with vaginal bleeding, including menstruation within past 24 hours21
- •Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
- •Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)
结局指标
主要结局
Comparison parameter
时间窗: 12 months
Number of visits (from initial visit until the cause of vaginitis is detected)
次要结局
未报告次要终点