Clinical trial NCT04453956: A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoma
Keywords: Polyp Detection
Quality Monitoring
Artificial Intelligence
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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 .

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or above;
2. Colonoscopy is needed to further characterize gastrointestinal diseases;
3. Ability to read, understand and sign informed consent forms;
4. 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:

1. Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
2. Participate in a drug clinical trial and during the elution period of the trial or control drug；
3. Drug or alcohol abuse or mental disorder in the last 5 years;
4. Pregnant or lactating women;
5. Patients with multiple polyp syndrome;
6. Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
7. Patients with known perforation or colonic obstruction;
8. Patients with a contraindication for biopsy;
9. The researchers did not consider the subjects suitable for colonoscopy;
10. The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 3 Months
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 3 months
measure: The mean number of polyps per procedure
timeFrame: 3 months
measure: The mean number of adenomas per procedure
timeFrame: 3 months
measure: Detection rate of large, small and diminutive polyps
timeFrame: 3 months
measure: The mean number of large, small and diminutive polyps per procedure
timeFrame: 3 months
measure: Detection rate of large, small and diminutive adenomas
timeFrame: 3 months
measure: The mean number of large, small and diminutive adenomas per procedure
timeFrame: 3 months
measure: Detection rate of adenoma in different sites
timeFrame: 3 months
measure: The mean number of adenomas in different sites per procedure
timeFrame: 3 months
measure: Time of colonoscopic insertion
timeFrame: 3 months
measure: Time of colonoscopic withdrawal
timeFrame: 3 months
measure: Cecal intubation rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References:
citation: Yao L, Zhang L, Liu J, Zhou W, He C, Zhang J, Wu L, Wang H, Xu Y, Gong D, Xu M, Li X, Bai Y, Gong R, Sharma P, Yu H. Effect of an artificial intelligence-based quality improvement system on efficacy of a computer-aided detection system in colonoscopy: a four-group parallel study. Endoscopy. 2022 Aug;54(8):757-768. doi: 10.1055/a-1706-6174. Epub 2022 Feb 4.