Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,060
- 试验地点
- 4
- 主要终点
- Develop and validate a Multimodal Mobile Colposcope (MMC)
研究概览
简要总结
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >25 years of age;
- •Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
- •Women of childbearing potential must have a negative urine or blood pregnancy test;
- •Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.
排除标准
- •Women under 25 years of age;
- •Women who have undergone hysterectomy with removal of the cervix;
- •Women with known allergy to proflavine or acriflavine;
- •Women who are pregnant or nursing at the time of enrollment;
- •Incapacitated women or in vulnerable situations or who are not willing to give consent;
结局指标
主要结局
Develop and validate a Multimodal Mobile Colposcope (MMC)
时间窗: Day 1 - at the colposcopy day
Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)
次要结局
未报告次要终点