Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,379
- 试验地点
- 2
- 主要终点
- Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
研究概览
简要总结
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
详细描述
Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.
Consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of CDSD. Sensitivity and specificity of CDSD-unaided and CDSD-aided predictions will be compared with the ground truth of histopathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The pathologist (outcomes assessor) is blinded to the endoscopist predictions and CDSD prediction.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Willing and able to provide informed consent
- •Subjects undergoing colonoscopy
排除标准
- •Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
- •Inflammatory Bowel Disease
- •Hereditary Non Polyposis Colorectal Cancer
- •Severe coagulopathy
- •Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
- •No diminutive polyps detected during colonoscopy
结局指标
主要结局
Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
时间窗: Upon receipt of pathology results (within one week)
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.
次要结局
- 1. Number of Unaided NBI Prediction and Pathology Result of Diminutive Polyps Detected by the Endoscopist and Confirmed by Pathology for Which CDSD Does Not Return a Prediction.(Upon receipt of pathology results (within one week))
- 2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.(Upon receipt of pathology results (within one week))
- 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.(Upon receipt of pathology results (within one week))
- 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.(Upon receipt of pathology results (within one week))
- 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.(Upon receipt of pathology results (within one week))
- 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD(Upon receipt of pathology results (within one week))