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

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Polyps
• Intervention / Treatment: Other: Endoangel assisted the process of colonoscopy; Other: Colonoscopy was performed without endoangel assistance

• Study Type: Interventional
• Enrollment (Actual): 1360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physician AI-assisted diagnosis group	Other: Endoangel assisted the process of colonoscopy; Endoangel assisted doctors to detect polyps
Sham Comparator: Physician Independent Diagnostic Group	Other: Colonoscopy was performed without endoangel assistance; Polyps were detected without ENDOANGEL assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity of polyps identification	The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.	3 months
specificity of polyps identification	The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	The numerator is subjects with polyps detected and the denominator is all subjects.	3 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Peking University Cancer Hospital & Institute; Wuhan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2021
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps
• Other Study ID Numbers: EndoAngel -CTP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No