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

NCT ID: NCT04102631

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1076 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2019-12-31

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.

Conditions

Adenoma Detection Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

exposed group

patients will receive colonoscopy with assistance of Endo.Angel

Group Type: EXPERIMENTAL

colonoscopy with assistance of Endo.Angel

Intervention Type: DIAGNOSTIC_TEST

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.

non-exposed group

patients will receive colonoscopy without assistance of Endo.Angel

Group Type: SHAM_COMPARATOR

colonoscopy without assistance of Endo.Angel

Intervention Type: DIAGNOSTIC_TEST

Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

colonoscopy without assistance of Endo.Angel

Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Yu Honggang

Chief of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Honggang Yu, MD

Role: CONTACT

yuhonggang1968@163.com

+8613871281899

Facility Contacts

Honggang Yu, MD

Role: primary

yuhonggang1968@163.com

+8613871281899

Other Identifiers

EA-18-002

Identifier Type: -

Identifier Source: org_study_id