A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy

Wuhan University

Status: Unknown

Conditions: Adenoma

Treatments: Diagnostic Test: Colonoscopy without the assistance of EndoAngel's any function.; Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.; Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.

Study type: Interventional

Funder types: Other

Identifiers

NCT04453956

EA-19-001

Details and patient eligibility

About

An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.

Full description

The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can 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 evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .

Enrollment: 1,090 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
7. Patients with known perforation or colonic obstruction;
8. Patients with a contraindication for biopsy;
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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,090 participants in 4 patient groups

Control group

Sham Comparator group

Description:

Patients will receive colonoscopy without assistance of EndoAngel's any function.

Treatment:

Diagnostic Test: Colonoscopy without the assistance of EndoAngel's any function.

Polyp detection function group

Experimental group

Description:

Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.

Treatment:

Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.

Quality monitoring function group

Experimental group

Description:

Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.

Treatment:

Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.

Polyp detection plus quality monitoring functions group

Experimental group

Description:

Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.

Treatment:

Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.

Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.