NCT04135716

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,076 (estimated)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adenoma

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	Colonoscopy without assistance of Endo.Angel	Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.

Timeline

• Start date: 2019-11-28
• Primary completion: 2020-03-01
• Completion: 2020-07-01
• First posted: 2019-10-23
• Last updated: 2019-10-23

Locations

1 site across 1 country: China