Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Image quality
研究概览
简要总结
This trial studies whether hyperspectral endoscopy improves visualization of abnormal tissue in average risk patients during standard-of-care colonoscopies. Hyperspectral endoscopy is an emerging technique that has the potential to enable the signals from blood to be resolved from tissue-specific signals. Image-enhanced endoscopy may improve visualization of abnormal colonic tissue when compared to the standard-of-care high-definition white light endoscopy.
详细描述
PRIMARY OBJECTIVE:
I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.
SECONDARY OBJECTIVES:
I. To assess whether use of HySE could reduce the rate of missed flat polyps.
II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients scheduled for a standard of care screening or surveillance colonoscopy
排除标准
- •Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure
结局指标
主要结局
Image quality
时间窗: 1 year
Assessed by the endoscopist, based on level of confidence in delineating the area of interest. Will assess and compare the number of polyps found by standard light endoscopy and narrow band imaging with hyperspectral endoscopy.
Spectral profiles corresponding to normal versus abnormal colonic tissue
时间窗: 1 year
Will apply a multivariate statistical analysis such as spectral angle mapper to determine whether the spectra are significantly different as determined by light spectral bandwidth measurements.
次要结局
- Imaging differences in polyp characteristics documented upon post-procedure video review(1 year)
研究者
Vassiliki Tsikitis
Principal Investigator
OHSU Knight Cancer Institute