A Prospective, Randomized, Single-blind, Parallel-controlled Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,076
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Colonoscopy is a key technique in the detection and diagnosis of lower gastrointestinal diseases. High quality endoscopy results in better disease outcomes. However, the operant level of different endoscopists is significantly different.This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.
详细描述
This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.Criteria for inclusion and exclusion are determined prior to endoscopic examination. Candidates who meet all inclusion criteria as well as do not meet all exclusion criteria are bring into the study. Participants randomized before the examination, they are divided into the exposed group assisted by Endo.Angel or the non-exposed group without Endo.Angel. Followup are conducted after the examination.Study will be finished when all followup is done,and the examination result collected from participants will send to an independent review data analysis group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Men or women over the age of 18 years old;
- •Ability to read, understand and sign informed consent;
- •The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all the research procedures and follow-up visits in conjunction with the research procedure.
排除标准
- •Colonoscopy patients with absolute contraindications;
- •patients with biopsy contraindications;
- •inflammatory bowel disease, colorectal cancer, history of colorectal surgery;
- •women during pregnancy or lactation;
- •Patients with multiple polyposis syndrome;
- •Patients with known or suspected intestinal obstruction or perforation
- •Previously failed colonoscopy;
- •The investigator believes that the subject is not suitable for high-risk disease or other special conditions in clinical trials.
研究组 & 干预措施
Exposed group
Patients will receive colonoscopy with assistance of Endo.Angel
干预措施: Colonoscopy with assistance of Endo.Angel (Diagnostic Test)
Non-exposed group
Patients will receive colonoscopy without assistance of Endo.Angel
干预措施: Colonoscopy without assistance of Endo.Angel (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 adenoma detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
次要结局
- Detection rate of large, small and minimal adenomas(3 months.)
- The mean number of adenomas per procedure(3 months.)
- Detection rate of large, small and minimal polyps(3 months.)
- The mean number of large, small and minimal polyps per procedure(3 months.)
- Polyp Detection Rate(3 months.)
- The mean number of polyps per procedure(3 months.)