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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician AI-assisted diagnosis group | Experimental |
| |
| Physician Independent Diagnostic Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The reading process is assisted by ENDOANGEL | Other | Diagnosis of benign and malignant lesions with the help of ENDOANGEL |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song He, MD | Contact | +8613808336120 | dengchao1990@hospital.cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| No ENDOANGEL assistance during the reading process | Other | Diagnosis of benign and malignant lesions without the help of ENDOANGEL |
|
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 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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