NCT02767726终止不适用
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of suspicious lesions identified
研究概览
简要总结
Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
- •Subjects are 18 years of age or older
- •Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
- •Subjects are women.
排除标准
- •Pregnancy.
- •Males (males do not have a cervix and thus cannot undergo colposcopy).
结局指标
主要结局
Number of suspicious lesions identified
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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