NCT02908607Unknown1 期
Thermal Imaging for Cervical Cancer Screening and Early Detection
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging
研究概览
简要总结
When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.
Thus, a technology that improves the accuracy of the colposcopic exam is needed.
This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Age > 18
- •Women with premalignant cervical lesions who are candidates for conization (group A)
- •Women with a normal cervix who are candidates for hysterectomy (group B)
- •Women with newly diagnosed cervical cancer
排除标准
- •For group A and B - women that had conization in the past
研究组 & 干预措施
experimental
Experimental
3 groups of patients will be participated: women with cancer, women with premalignant lesions and women with a normal cervix. All patients will undergo the same examination
干预措施: Thermal imaging (Device)
结局指标
主要结局
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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