Clinical trial NCT04135716: A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Official title: A Prospective, Randomized, Single-blind, Parallel-controlled Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoma
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 1076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization results were kept confidential in the general case, and information on the use of EndoAngel was not reflected in the hospital history and documents obtained by other subjects. During the examination and after the examination, researchers should take care to avoid talking to the subjects about random content and avoid unnecessary blindness.

The evaluator was blinded, and neither the data analysis team nor the pathologist could obtain random result information from the medical history data, regardless of whether the subject used EndoAngel or not.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 3 months.
Secondary outcomes:
measure: The mean number of polyps per procedure
timeFrame: 3 months.
measure: Polyp Detection Rate
timeFrame: 3 months.
measure: The mean number of adenomas per procedure
timeFrame: 3 months.
measure: Detection rate of large, small and minimal polyps
timeFrame: 3 months.
measure: The mean number of large, small and minimal polyps per procedure
timeFrame: 3 months.
measure: Detection rate of large, small and minimal adenomas
timeFrame: 3 months.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: