A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy

Adenoma Clinical Trial

Official title:

A Prospective, Randomized, Single-blind, Parallel-controlled Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04135716
• Other study ID #: EA-18-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2019
• 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

Colonoscopy is a key technique in the detection and diagnosis of lower gastrointestinal diseases. High quality endoscopy results in better disease outcomes. However, the operant level of different endoscopists is significantly different.This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.

Description:

This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.Criteria for inclusion and exclusion are determined prior to endoscopic examination. Candidates who meet all inclusion criteria as well as do not meet all exclusion criteria are bring into the study. Participants randomized before the examination, they are divided into the exposed group assisted by Endo.Angel or the non-exposed group without Endo.Angel. Followup are conducted after the examination.Study will be finished when all followup is done,and the examination result collected from participants will send to an independent review data analysis group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1076
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men or women over the age of 18 years old;

2. Ability to read, understand and sign informed consent;

3. The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all the research procedures and follow-up visits in conjunction with the research procedure.

Exclusion Criteria:

1. Colonoscopy patients with absolute contraindications;

2. patients with biopsy contraindications;

3. inflammatory bowel disease, colorectal cancer, history of colorectal surgery;

4. women during pregnancy or lactation;

5. Patients with multiple polyposis syndrome;

6. Patients with known or suspected intestinal obstruction or perforation

7. Previously failed colonoscopy;

8. The investigator believes that the subject is not suitable for high-risk disease or other special conditions in clinical trials.

Related Conditions & MeSH terms

• Adenoma

Intervention

Diagnostic Test:
• Colonoscopy with assistance of Endo.Angel
Patients in exposed group will receive colonoscopy with assistance of Endo.Angel,a real-time quality monitoring system based on computer vision,which is used to 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.
• Colonoscopy without assistance of Endo.Angel
Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.

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 adenoma 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	Polyp Detection Rate	The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients receiving 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 minimal polyps	The numerator was the number of patients with large (=10 mm), small (4-9 mm), and minimal(=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 minimal polyps per procedure	The numerator was the number of large (=10 mm), small (4-9 mm), and minimal (=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 minimal adenomas	The numerator was the number of patients with large (=10 mm), small (4-9 mm), and minimal(=5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy	3 months.