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

Study Overview
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Brief Summary
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The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Other: The reading process is assisted by ENDOANGEL
* Other: No ENDOANGEL assistance during the reading process


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18, male or female； Cases with complete, clear imaging data, including images under white light and magnified stained images； Complete pathological diagnosis of upper digestive tract lesions; The included cases were excluded from the software development. Exclusion Criteria: Cases whose image data did not meet the evaluation requirements; The investigator considered the case unsuitable for the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician AI-assisted diagnosis group<br> | Other: The reading process is assisted by ENDOANGEL<br>* Diagnosis of benign and malignant lesions with the help of ENDOANGEL<br>|
| Sham Comparator: Physician Independent Diagnostic Group<br> | Other: No ENDOANGEL assistance during the reading process<br>* Diagnosis of benign and malignant lesions without the help of ENDOANGEL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFROC-AUC | AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer identification Sensitivity | The numerator is the number of true positives and the denominator is the total number of true positives and false negatives. | 3 months | 
| Cancer identification specificity | The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives. | 3 months | 
| Cancer Identification Diagnosis Compliance Rate | The numerator is the total number of true positives plus true negatives, and the denominator is the total number of true positives, false positives, true negatives, and false negatives. | 3 months |