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

Renmin Hospital of Wuhan University1,076 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

1,076

Conditions

Adenoma Detection Rate

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 known space-occupying tumor or intestinal stenosis; 7. Patients with known perforation or colonic obstruction; 8. A history of anaphylaxis with antispasmodic has been documented; 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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

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.

Time frame: 3 months

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.

Time frame: 3 months

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

Time frame: 3 months

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.

Time frame: 3 months

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

Time frame: 3 months

The mean number of large, small and minimal adenomas per procedure

The numerator was the number of 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.

Time frame: 3 months

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.

Time frame: 3 months

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.

Time frame: 3 months

Time of colonoscopic withdrawal

the duration of colonoscopic withdrawal(not include the time of biopsy or treatment).

Time frame: 3 months

Time of colonoscopic insertion

The time of colonoscopy from the rectum to the ileocecal area.

Time frame: 3 months

The rate of reaching the ileocecal region

The numerator is the number of cases of colonic examination reaching the ileocecal region, and the denominator is the total number of colonoscopy cases.

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts