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

Wuhan University

Status: Unknown

Conditions: Adenoma

Treatments: Diagnostic Test: Colonoscopy with assistance of Endo.Angel; Diagnostic Test: Colonoscopy without assistance of Endo.Angel

Study type: Interventional

Funder types: Other

Identifiers

NCT04135716

EA-18-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,076 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,076 participants in 2 patient groups

Exposed group

Experimental group

Description:

Patients will receive colonoscopy with assistance of Endo.Angel

Treatment:

Diagnostic Test: Colonoscopy with assistance of Endo.Angel

Non-exposed group

Sham Comparator group

Description:

Patients will receive colonoscopy without assistance of Endo.Angel

Treatment:

Diagnostic Test: Colonoscopy without assistance of Endo.Angel