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

Not Applicable

• Conditions: Adenoma
• Interventions: Diagnostic Test: Colonoscopy without assistance of Endo.Angel; Diagnostic Test: Colonoscopy with assistance of Endo.Angel

• Registration Number: NCT04135716
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-20
• Study First Submitted QC: 2019-10-20
• Last Update Submitted: 2019-10-20
• Study First Posted: 2019-10-23
• Last Update Posted: 2019-10-23
• Study Start: 2019-11-28
• Primary Completion: 2020-03-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1076

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-exposed group	Colonoscopy without assistance of Endo.Angel	Patients will receive colonoscopy without assistance of Endo.Angel
Exposed group	Colonoscopy with assistance of Endo.Angel	Patients will receive colonoscopy with assistance of Endo.Angel

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	3 months.	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.

Secondary Outcome Measures

Name	Time	Method
Detection rate of large, small and minimal adenomas	3 months.	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
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
Detection rate of large, small and minimal polyps	3 months.	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
The mean number of large, small and minimal polyps per procedure	3 months.	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
Polyp Detection Rate	3 months.	The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
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.

Trial Locations

Locations (1)

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