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Development of AI-assisted real-time diagnosis system for early gastric cancer based on confocal images under digestive endoscopy

Development of AI-assisted real-time diagnosis system for early gastric cancer based on confocal images under digestive endoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093950
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-31
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early gastric cancer

Interventions

Index test:Probe confocal microendoscope

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-70 years old; 2. Gender: 50/50 between men and women; 3, with fatigue, anemia, abdominal distension, diarrhea, abdominal pain, nausea, black stool and other discomfort patients.

Exclusion criteria

Exclusion criteria: 1, delirium, mental disorder can not cooperate or coma, shock and other critical state; 2. People who are allergic to fluorescein sodium contrast agent and allergic constitution; 3. Patients with severe throat diseases, corrosive gastritis, corrosive esophagitis, large esophageal diverticulum, aortic aneurysm, and severe cervical and thoracic spinal malformations; 4, serious cardiopulmonary diseases, such as heart failure, myocardial infarction, severe arrhythmia, respiratory failure, bronchial asthma attack period; 5. Subjects with evidence of pathogenic infection, subjects with Clostridium difficile or other intestinal infections (CMV, EBV, fungi, etc.) within 30 days of endoscopic screening, or subjects with Clostridium difficile toxin assay or other intestinal pathogens (CMV, EBV, fungi, etc.) screening positive; 6, acute viral hepatitis or intestinal infectious diseases; 7. Patients with severe liver disease or patients who experienced major trauma or underwent major surgery within 4 weeks of screening visit; 8, screening visit bilirubin, transaminase (ALT\AST) more than 2 times the upper limit of normal; 9, eGFR<60ml/min or dialysis patients or uremia; 10. Patients with evidence of coagulation dysfunction: PLT<90g/L; 11. Subjects who currently have or have a history of severe, progressive, or uncontrolled kidney, liver, blood, digestive, metabolic, endocrine, lung, heart, or nervous system disease; 12. Female subjects who were pregnant during pregnancy, lactation, or planned to be enrolled in the study; 13. Have malignant tumor or history of malignant tumor; 14. Subjects infected with HIV, HBV, HCV; 15. Patients with prolonged QTc, hypokalemia, who are using drugs that can prolong QTc, and those with heart disease should not use this product; 16, can not cooperate to complete the research process; 17. Participated in other clinical medical research within 3 months before baseline; 18. Any other circumstances that the investigator believes would render the subject unfit for study.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactYang Cuiping

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

yangcuipingsgh@163.com+86 187 4719 3644

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026