A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Enteroscope

Artificial Intelligence

Intestinal Polyposis, Adenomatous

Treatments

Device: DeFrame

Study type

Interventional

Funder types

Other

Identifiers

NCT05687318

PekingUMCH-1

Details and patient eligibility

About

A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.

Enrollment

337 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age of 18 to 85 years old, regardless of gender;
electronic colonoscopy is required;
The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.

Exclusion criteria

(1) Contraindications associated with electronic colonoscopy or biopsy;
(2) poor intestinal preparation;
(3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
(4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
(5) acute abdominal or intestinal inflammation;
(6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
(7) Participated in other interventional clinical trials within 1 month before enrollment;
(8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.