A Prospective, Randomized, Single-blind, 2 × 2 Factorial Design Single Center Study Evaluating the Polyp Detection and Quality Monitoring Function of EndoAngel in Improving the Quality of Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.
详细描述
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Male or female aged 18 years or above;
- •Colonoscopy is needed to further characterize gastrointestinal diseases;
- •Ability to read, understand and sign informed consent forms;
- •The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.
排除标准
- •Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
- •Participate in a drug clinical trial and during the elution period of the trial or control drug；
- •Drug or alcohol abuse or mental disorder in the last 5 years;
- •Pregnant or lactating women;
- •Patients with multiple polyp syndrome;
- •Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- •Patients with known perforation or colonic obstruction;
- •Patients with a contraindication for biopsy;
- •The researchers did not consider the subjects suitable for colonoscopy;
- •The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
研究组 & 干预措施
Control group
Patients will receive colonoscopy without assistance of EndoAngel's any function.
干预措施: Colonoscopy without the assistance of EndoAngel's any function. (Diagnostic Test)
Polyp detection function group
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
干预措施: Colonoscopy with the assistance of EndoAngel's polyp detection function. (Diagnostic Test)
Quality monitoring function group
Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
干预措施: Colonoscopy with the assistance of EndoAngel's quality monitoring function. (Diagnostic Test)
Polyp detection plus quality monitoring functions group
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
干预措施: Colonoscopy with the assistance of EndoAngel's polyp detection function. (Diagnostic Test)
Polyp detection plus quality monitoring functions group
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
干预措施: Colonoscopy with the assistance of EndoAngel's quality monitoring function. (Diagnostic Test)
结局指标
主要结局
Adenoma detection rate
时间窗: 3 Months
The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
次要结局
- Cecal intubation rate(3 months)
- The mean number of polyps per procedure(3 months)
- The mean number of adenomas per procedure(3 months)
- The mean number of large, small and diminutive adenomas per procedure(3 months)
- The mean number of adenomas in different sites per procedure(3 months)
- Time of colonoscopic insertion(3 months)
- Time of colonoscopic withdrawal(3 months)
- Polyp detection rate(3 months)
- Detection rate of adenoma in different sites(3 months)
- Detection rate of large, small and diminutive polyps(3 months)
- The mean number of large, small and diminutive polyps per procedure(3 months)
- Detection rate of large, small and diminutive adenomas(3 months)