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
- 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 known space-occupying tumor or intestinal stenosis;
- •Patients with known perforation or colonic obstruction;
- •A history of anaphylaxis with antispasmodic has been documented;
- •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
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
- The mean number of adenomas per procedure(3 months)
- Polyp Detection Rate(3 months)
- Detection rate of large, small and minimal polyps(3 months)
- The rate of reaching the ileocecal region(3 months)
- The mean number of polyps per procedure(3 months)
- The mean number of large, small and minimal polyps per procedure(3 months)
- The mean number of large, small and minimal adenomas per procedure(3 months)
- Time of colonoscopic withdrawal(3 months)
- Time of colonoscopic insertion(3 months)
- The mean number of adenomas in different sites per procedure(3 months)
- Detection rate of large, small and minimal adenomas(3 months)
- Detection rate of adenoma in different sites(3 months)
研究者
Yu Honggang
Chief of Department of Gastroenterology
Renmin Hospital of Wuhan University