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

NCT ID: NCT05481632

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-17
• Study Completion Date: 2022-03-04

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.

Conditions

Intestinal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Physician AI-assisted diagnosis group

Group Type: EXPERIMENTAL

Endoangel assisted the process of colonoscopy

Intervention Type: OTHER

Endoangel assisted doctors to detect polyps

Physician Independent Diagnostic Group

Group Type: SHAM_COMPARATOR

Colonoscopy was performed without endoangel assistance

Intervention Type: OTHER

Polyps were detected without ENDOANGEL assistance

Interventions

Endoangel assisted the process of colonoscopy

Endoangel assisted doctors to detect polyps

Intervention Type: OTHER

Colonoscopy was performed without endoangel assistance

Polyps were detected without ENDOANGEL assistance

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Wuhan Central Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EndoAngel -CTP-01

Identifier Type: -

Identifier Source: org_study_id