A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Comparison of infrared spectroscopy with routine histopathology
研究概览
简要总结
The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.
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
- 否
入选标准
- •Patients undergoing hysteroscopy
排除标准
- •Pregnancy
研究组 & 干预措施
Women undergoing hysteroscopy
Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
干预措施: Hysteroscopy (Procedure)
Women undergoing hysteroscopy
Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
干预措施: Infrared Spectroscopy (Device)
结局指标
主要结局
Comparison of infrared spectroscopy with routine histopathology
时间窗: 3 years
Tissue smears that have undergone infrared spectroscopy during hysteroscopy will have a different spectral absorption than healthy tissue, thus indicating malignancy. These results will be compared to the results of routine histopathology to determine accuracy of spectroscopy to indicate malignancy.
次要结局
未报告次要终点