Validation of AI-ENDO System in Endoscopic Submucosal Dissection

Recruiting now · Not applicable

Conditions studied: Superficial Esophageal, Gastric or Colorectal Lesions

In brief

This study is a pilot trial designed to evaluate the feasibility and safety of Al-ENDO assisted ESD in patients with gastrointestinal superficial lesions. Patients with gastrointestinal superficial lesions are scheduled for conventional ESD will be screened for eligibility. The study consists of a few stages: 1. In the first phase, the Al-ENDO system will be tested in the background of the ESD procedure prospectively, but without interfering the endoscopists. The Al-ENDO system would be installed in the Endoscopy Centre in Prince of Wales Hospital. Real-time video analysis would be conducted in the background without interference of the endoscopists' performance. A total of 30 clinical ESD procedures would be analysed, with the goal of achieving good accuracy of the system. The data obtained from this group of patients would also serve as control group for comparison with the subsequent procedures with Al-ENDO support. 2. The second phase of the study would comprise of a the prospective pilot study which Al-ENDO system would be connected to the endoscopy tower with the auxiliary output monitor placing side-by-side with the endoscopy main monitor. The GUI would be displayed in the auxiliary monitor. This phase aims to demonstrate device and patients' safety throughout the procedure, and a total of 10 patients would be recruited, with the target of ensuring smooth dissection procedure without system interruption of failure. In this phase of the study, only expert endoscopist would be involved in performing the procedure. 3. The third phase of the study comprises of a continuation of the initial pilot study with additional of 20 more patients, so that total of 30 procedures would be performed to compare the clinical outcomes with the control group collected previously.

Key facts

Study ID

NCT07392268

Run by

Chinese University of Hong Kong

People needed

60

Starts

2025-05-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with superficial esophageal, gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).
• Age between 18 and 85.

You may not qualify if…

• Patient who refused to participate.
• Other cases deemed by the examining physician as unsuitable for safe treatment.

Where it is running

• Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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