A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy

Not Applicable

• Conditions: Adenoma
• Interventions: Diagnostic Test: Colonoscopy without the assistance of EndoAngel's any function.; Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.; Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.

• Registration Number: NCT04453956
• Lead Sponsor: Renmin Hospital of Wuhan University

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 .

Study Timeline

• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Primary Completion: 2020-10-20
• Last Update Posted: 2020-10-22
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1090

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group	Colonoscopy without the assistance of EndoAngel's any function.	Patients will receive colonoscopy without assistance of EndoAngel's any function.
Quality monitoring function group	Colonoscopy with the assistance of EndoAngel's quality monitoring function.	Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
Polyp detection plus quality monitoring functions group	Colonoscopy with the assistance of EndoAngel's polyp detection function.	Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Polyp detection plus quality monitoring functions group	Colonoscopy with the assistance of EndoAngel's quality monitoring function.	Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Polyp detection function group	Colonoscopy with the assistance of EndoAngel's polyp detection function.	Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	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 Outcome Measures

Name	Time	Method
Cecal intubation rate	3 months	The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.
The mean number of polyps per procedure	3 months	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The mean number of adenomas per procedure	3 months	The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The mean number of large, small and diminutive adenomas per procedure	3 months	The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of adenomas in different sites per procedure	3 months	The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time of colonoscopic insertion	3 months	The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening
Time of colonoscopic withdrawal	3 months	The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
Polyp detection rate	3 months	The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Detection rate of adenoma in different sites	3 months	The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Detection rate of large, small and diminutive polyps	3 months	The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of large, small and diminutive polyps per procedure	3 months	The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Detection rate of large, small and diminutive adenomas	3 months	The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China