Cervical Cancer Detection Using Optical Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Identification of optical signatures of cervical tissue
研究概览
简要总结
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
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
- •undergoing colposcopy for the diagnosis of cervical cancer
- •LEEP for the treatment of cervical cancer in early stages.
- •Follow-up Pap smear in surveillance
排除标准
- •Women under the age of 18 (minors) will be excluded from this study.
- •patients will be excluded if she has had a recent episode of bleeding or preterm labor.
- •Subjects who are not competent to give consent will excluded
研究组 & 干预措施
Colposcope
Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
干预措施: Optical Spectroscopy Bench-Top System (Device)
Colposcope
Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
干预措施: Portable Optical Spectrometer (Device)
Colposcope
Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
干预措施: Transvaginal colposcope (Device)
结局指标
主要结局
Identification of optical signatures of cervical tissue
时间窗: Day of procedure (less than 10 minutes)
The primary outcome of this study is the identification of the optical signatures of cervical tissue.
次要结局
未报告次要终点