NCT02903394已完成不适用
Coherence Imaging of the Cervical Epithelium
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of Patients With Interferometric Data Acquired From Cervical Epithelium
研究概览
简要总结
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •able to provide informed consent
- •willing to abstain from sexual intercourse for at least 24 hours before study visit
排除标准
- •using an intrauterine device (IUD)
- •have a current gynecological infection or discharge
- •have had any cervical surgery
- •had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
- •currently enrolled in any research studies involving the application of vaginal formulations
- •employed or supervised by the study investigators
- •have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
研究组 & 干预措施
mLCI imaging
Experimental
mLCI device images cervical epithelium
干预措施: mLCI Device (Device)
结局指标
主要结局
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
时间窗: day 1
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
次要结局
- Number and Frequency of Adverse Events(day 1)
- Number of Patients With Automated Classification of Cervical Epithelium(day 1)
研究者
研究点 (2)
Loading locations...
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