Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Clinical Utility and Validation of Novel AI-ENDO System in Endoscopic Submucosal Dissection

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patient with superficial esophageal, gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).

• Age between 18 and 85.

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Hon Chi Yip
hcyip@surgery.cuhk.edu.hk
+852 3505 2956
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: AI-ENDO assisted ESD
ESD performed with AI-ENDO assistance
Active_comparator: Conventional ESD
ESD performed as in usual clinical practice
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov