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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intestinal Polyps

Intervention / Treatment
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* Other: Endoangel assisted the process of colonoscopy
* Other: Colonoscopy was performed without endoangel assistance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |