Evaluation of an Artificial Intelligence System for Quality Control of Esophageal Endoscopy: A Multi-center, Randomized, Controlled, Blinded, Superiority Clinical Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086162

Enrollment

Unknown

Registered

2024-06-26

Start date

2024-06-30

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Esophageal lesions

Interventions

Experiment Group:When gastroscopy is performed, the "true" AI quality control system is activated, when the proportion of high-quality endoscopic images detected in real-time is too low, the AI qualit

Control Group:When performing gastroscopy, the "pseudo" AI quality control system is activated, which randomly sends or does not send an alarm signal

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age 18 to 80 years old; ? Suitable for upper gastrointestinal endoscopy examination; ? Informed consent of patients and their families; ? There are no known anatomical abnormalities in the esophagus, including esophageal diverticulum, esophagotracheal fistula, history of esophageal disease surgery, and history of esophageal cancer radiotherapy.

Exclusion criteria

Exclusion criteria: ? Pregnant women; ? Cannot suspend anticoagulant/antiplatelet therapy; ? There is coagulation disorder (PLT1.5).

Design outcomes

Primary

Measure	Time frame
Rate of high-quality gastroscopy;	—

Secondary

Measure	Time frame
The total time of a single esophageal endoscopy examination;Number of detected esophageal lesions;	—

Countries

China

Contacts

Public ContactMingyan Cai

Zhongshan Hospital, Fudan University

cai.mingyan@zs-hospital.sh.cn+86 138 1706 6559

Outcome results

None listed

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