Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Physician AI-assisted diagnosis group
|
Other: The reading process is assisted by ENDOANGEL
Diagnosis of benign and malignant lesions with the help of ENDOANGEL
|
| Sham Comparator: Physician Independent Diagnostic Group
|
Other: No ENDOANGEL assistance during the reading process
Diagnosis of benign and malignant lesions without the help of ENDOANGEL
|
Outcome Measures
Primary Outcome Measures
- AFROC-AUC [3 months]
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
Secondary Outcome Measures
- Cancer identification Sensitivity [3 months]
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
- Cancer identification specificity [3 months]
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
- Cancer Identification Diagnosis Compliance Rate [3 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18, male or female；
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Cases with complete, clear imaging data, including images under white light and magnified stained images；
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Complete pathological diagnosis of upper digestive tract lesions;
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The included cases were excluded from the software development.
Exclusion Criteria:
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Cases whose image data did not meet the evaluation requirements;
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The investigator considered the case unsuitable for the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Hospital of Chongqing Medical University | Chongqing | Chongqing | China | 400000 |
Sponsors and Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EndoAngel -CTP-02