Validation of AI-ENDO System in Endoscopic Submucosal Dissection

Summary

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.

Conditions

• Superficial Esophageal, Gastric or Colorectal Lesions

Interventions

DEVICE

AI-ENDO system

During procedure of AI-ENDO assisted ESD, the AI-ENDO system will be connected to the video output system of the main endoscopy processor, so that real-time video data could be fed to the AI-ENDO system for AI analysis. In ESD procedures with AI-ENDO assistance, an auxiliary monitor would be placed side-by-side to the main endoscopy output monitor. This enables endoscopist to simultaneously take reference to the AI interpreted videos.

PROCEDURE

Conventional ESD

The ESD procedure would be performed in the same manner as in usual clinical practice. In brief, after identification of the target lesion, submucosal injection will be performed to elevate the submucosal layer from the muscularis propria. Mucosal incision followed by submucosal dissection will be performed using dedicated ESD knives. Countertraction method could be utilized based on the endoscopists' personal preference. After successful resection and ensuring adequate haemostasis, the specimen would be retrieved for pathological evaluation.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• Hong Kong

Study Locations