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

Ruijin Hospital1 site in 1 country1,360 target enrollmentJanuary 17, 2021

ConditionsIntestinal Polyps

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intestinal Polyps
Sponsor: Ruijin Hospital
Enrollment: 1360
Locations: 1
Primary Endpoint: sensitivity of polyps identification
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 17, 2021

End Date

March 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.