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

Adenoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04453956
• Other study ID #: EA-19-001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2020
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, MD
• Phone: +8613871281899
• Email: yuhonggang1968[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1090
• Est. completion date: October 30, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma

Intervention

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.
• 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.
• Colonoscopy without the assistance of EndoAngel's any function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of colonoscopic insertion	The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening	3 months
Secondary	Time of colonoscopic withdrawal	The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.	3 months
Secondary	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