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Study of AI Chromoendoscopy system for detection of early stage esophageal squamous cell carcinoma: a single-center, randomized, open-label, controlled, clinical trials

Study of AI Chromoendoscopy system for detection of early stage esophageal squamous cell carcinoma: a single-center, randomized, open-label, controlled, clinical trials

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050654
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

early stage esophageal cancer

Interventions

CAD-NBI group:The esophagus was observed in NBI mode, and the diagnosis was assisted by an artificial intelligence system
control group:The esophagus was observed in NBI mode

Sponsors

Shanghai Xuhui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Suitable for upper gastrointestinal endoscopy; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients were confirmed diagnosis of esophageal neoplastic lesion. 2. Patients undergoing emergency examination (treatment) of the upper gastrointestinal tract due to hematemesis, abdominal pain, etc.; 3. The American Society of Anesthesiologists (ASA) classification is greater than III; 4. Pregnancy and lactation; 5. Patients who cannot complete gastroscopy due to esophageal stricture or obstruction; 6. The patients or their families cannot understand the conditions and objectives of this study. 7. other reasons that made the subject ineligible to participate in this study, at the discretion of the chief investigator.

Design outcomes

Primary

MeasureTime frame
Detection rate of early esophageal squamous cell carcinoma;

Secondary

MeasureTime frame
False positive rate;false negative rate;

Countries

China

Contacts

Public ContactZhong Yunshi

Zhongshan Hospital of Fudan University

zhong.yunshi@zs-hospital.sh.cn+86 135 6462 3481

Outcome results

None listed

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