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

Adenoma Detection Rate 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: Recruiting

Administrative data

• NCT number: NCT04102631
• Other study ID #: EA-18-002
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 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: Recruiting
• Enrollment: 1076
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate

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
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Time of colonoscopic withdrawal	the duration of colonoscopic withdrawal(not include the time of biopsy or treatment).	3 months
Secondary	Time of colonoscopic insertion	The time of colonoscopy from the rectum to the ileocecal area.	3 months
Secondary	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.	3 months