AI-ENDO assistance for endoscopic submucosal dissection (ESD)
Clinical Utility and Validation of Novel AI-ENDO System in Endoscopic Submucosal Dissection
NA · Chinese University of Hong Kong · NCT07392268
This pilot will try using the AI-ENDO system to help doctors perform ESD in adults with superficial esophageal, stomach, or colorectal lesions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07392268 on ClinicalTrials.gov |
What this trial studies
The trial tests the AI-ENDO software during ESD procedures on adults with superficial lesions of the esophagus, stomach, or colon. In the first phase the system will run in the background for 30 conventional ESD cases to analyse real-time video without affecting the endoscopist and to provide a control dataset. A subsequent phase will use AI-ENDO to provide active, real-time support to endoscopists and compare technical and safety outcomes versus the background cases. All procedures are performed at the Endoscopy Centre of Prince of Wales Hospital under the Chinese University of Hong Kong.
Who should consider this trial
Good fit: Adults aged 18–85 scheduled for conventional ESD for superficial esophageal, gastric, or colorectal lesions who can provide informed consent are the intended participants.
Not a fit: Patients with lesions unsuitable for ESD, those requiring alternative or more advanced cancer treatment, or people who decline participation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, AI-ENDO could improve completeness and safety of ESD by offering real-time guidance that may reduce procedure time and complications.
How similar studies have performed: AI tools have shown promise for lesion detection and characterization in endoscopy, but AI-assisted guidance specifically for ESD is still early and has limited clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with superficial esophageal, gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD). * Age between 18 and 85. Exclusion Criteria: * Patient who refused to participate. * Other cases deemed by the examining physician as unsuitable for safe treatment.
Where this trial is running
Hong Kong
- Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Hon Chi Yip
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: +852 3505 2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Superficial Esophageal, Gastric or Colorectal Lesions, Al-ENDO SYSTEM, ENDOSCOPIC SUBMUCOSAL DISSECTION, ESD