Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software

Shanghai Jiao Tong University

Status

Completed

Conditions

Intestinal Polyps

Treatments

Other: Colonoscopy was performed without endoangel assistance

Other: Endoangel assisted the process of colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT05481632

EndoAngel -CTP-01

Details and patient eligibility

About

To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.

Enrollment

1,360 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years old ≤ age ≤ 75 years old, male or female;
Subjects with colonoscopy diagnosis and screening needs;
Sign the Written Informed Consent Form;
With full capacity for civil conduct.

Exclusion criteria

History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
Patients who are taking aspirin, warfarin, and other anticoagulants;
Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
History of colorectal surgery;
Patients with familial adenomatous polyposis;
Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);
Patients who are participating in clinical trials of other drugs or medical devices;
Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.