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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adenoma
- Sponsor
- Renmin Hospital of Wuhan University
- Enrollment
- 1090
- Locations
- 1
- Primary Endpoint
- Adenoma detection rate
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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 .
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Adenoma detection rate
Time Frame: 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.
Secondary Outcomes
- 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)