A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Image Quality Scores Using Likert Scale
研究概览
简要总结
The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.
详细描述
No additional description required.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred for diagnostic endoscopy or colonoscopy
- •Ability to comply and willingness to partake in study
排除标准
- •less than 21 years of age
- •is an inmate
结局指标
主要结局
Image Quality Scores Using Likert Scale
时间窗: One day
Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI. Likert Scores: 1. Not seen; 2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; 3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 4. very good; allows an excellent assesssment, anatomical details are clearly defined; details clear
次要结局
未报告次要终点