A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Missed detection rate of ≥5mm adenoma
研究概览
简要总结
To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥
- •Subjects who meet all of the following specific criteria will be considered for participation in the study:
- •Male or female with age ≥ 45 years inclusive;
- •Able to read, understand and sign informed consent;
- •The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures.
排除标准
- •Subjects who meet any of the following specific criteria will be refused to participate in the study:
- •have a history of drug or alcohol abuse or psychological disorders within the last 5 years;
- •Pregnant or lactating women;
- •Patients with known multiple polyp syndrome;
- •patients with known inflammatory bowel disease;
- •known intestinal stenosis or space-occupying tumor;
- •known colon obstruction or perforation;
- •patients with a history of colorectal surgery;
- •Patients with previous history of allergy to pre-used spasmolysis;
- •Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
- •High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
结局指标
主要结局
Missed detection rate of ≥5mm adenoma
时间窗: 6 months
(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.
次要结局
未报告次要终点
研究者
Yu Honggang
Professor
Renmin Hospital of Wuhan University