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Effect of an Artificial Intelligence Computer-Aided Detection and Diagnostic System on gastric neoplasm: A Multicenter Randomized Controlled Trial

Effect of an Artificial Intelligence Computer-Aided Detection and Diagnostic System on gastric neoplasm: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072016
Enrollment
Unknown
Registered
2023-05-31
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

gastric neoplasm

Interventions

SC-AI group:standard gastroscope is performed first, followed by AI-assisted gastroscope
AI-SC group:AI-assisted gastroscope is performed first, followed by standard gastroscope

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.18 years old and above,male or female; 2.Has the indication of or is willing to undergooutpatient gastroscopy examination; 3. Willing to and has the ability to sign or provide an informed consent

Exclusion criteria

Exclusion criteria: 1.History of gastric surgery; 2. Known gastric cancer, familial polyposis or inflammatory bowel disease involving the stomach; 3.Current anticoagulation therapy with a high risk of suspension, with high hemorrhagic risk to perform a polyp biopsy ; 4. Severe chronic renal failure (creatinine clearance180 mm Hg and/or arterial diastolic blood pressure >100 mm Hg); 8.Moderate or massive active GI bleeding (>100 mL/day); 9.Unable to tolerate sedation endoscopy

Design outcomes

Primary

MeasureTime frame
gastric neoplasm miss rate;

Secondary

MeasureTime frame
gastric neoplasm detection rate;biopsy rate;Number of gastric tumors per patient;gastric neoplasm patient miss rate; inspection time ;

Countries

China

Contacts

Public ContactQuanlin Li

Zhongshan Hospital, Fudan University

li.quanlin@zs-hospital.sh.cn+86 135 6467 1882

Outcome results

None listed

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