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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adenoma
• Intervention / Treatment: Diagnostic test: Colonoscopy without the assistance of EndoAngel's any function.; Diagnostic test: Colonoscopy with the assistance of EndoAngel's polyp detection function.; Diagnostic test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.

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 Type: Interventional
• Enrollment (Anticipated): 1090
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Patients will receive colonoscopy without assistance of EndoAngel's any function.	Diagnostic test: Colonoscopy without the assistance of EndoAngel's any function.; Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Experimental: Polyp detection function group; Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.	Diagnostic test: Colonoscopy with the assistance of EndoAngel's polyp detection function.; Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
Experimental: Quality monitoring function group; Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.	Diagnostic test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.; Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Experimental: Polyp detection plus quality monitoring functions group; Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.	Diagnostic test: Colonoscopy with the assistance of EndoAngel's polyp detection function.; Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.; Diagnostic test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.; Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	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.	3 months
The mean number of polyps per procedure	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.	3 months
The mean number of adenomas per procedure	The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.	3 months
Detection rate of large, small and diminutive polyps	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.	3 months
The mean number of large, small and diminutive polyps per procedure	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.	3 months
Detection rate of large, small and diminutive adenomas	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.	3 months
The mean number of large, small and diminutive adenomas per procedure	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.	3 months
Detection rate of adenoma in different sites	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.	3 months
The mean number of adenomas in different sites per procedure	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.	3 months
Time of colonoscopic insertion	The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening	3 months
Time of colonoscopic withdrawal	The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.	3 months
Cecal intubation rate	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.	3 months

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): October 20, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Polyp Detection; Quality Monitoring
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: EA-19-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No