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

Not Applicable

Completed

• Conditions: Intestinal Polyps
• Interventions: Other: Endoangel assisted the process of colonoscopy; Other: Colonoscopy was performed without endoangel assistance

• Registration Number: NCT05481632
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-17
• Primary Completion: 2021-07-16
• Study Completion: 2022-03-04
• Status Verified: 2022-07
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician AI-assisted diagnosis group	Endoangel assisted the process of colonoscopy	-
Physician Independent Diagnostic Group	Colonoscopy was performed without endoangel assistance	-

Primary Outcome Measures

Name	Time	Method
sensitivity of polyps identification	3 months	The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
specificity of polyps identification	3 months	The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate	3 months	The numerator is subjects with polyps detected and the denominator is all subjects.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China