Su2ura ESD Closure Pilot Study

This study is a single-center, prospective, single-arm, non-blinded first-in-human (FIH) early feasibility study intended to evaluate the short-term safety and technical feasibility of closure of gastric post-ESD defects using a novel through-the-scope full-thickness endoscopic suturing system in initial human use.

The subjects shall be patients scheduled to undergo ESD for gastric epithelial lesions at the study site (Prince of Wales Hospital) in Hong Kong who meet the eligibility criteria for this study and from whom written informed consent has been obtained. For the gastric defects created after completion of ESD, closure will be attempted using the study device, and its safety, technical success, and early postoperative maintenance of closure will be evaluated.

The target sample size of this study shall be 5 cases, and no control group shall be established. No comparison with existing defect closure techniques or verification of superiority will be performed. From the viewpoint of patient protection, comparatively controllable gastric post-ESD defects are selected as the entry model, and the safety signal and basic technical success of this device in its initial human use will be evaluated descriptively.

The device specifications used in this study shall remain fixed throughout the study period. During the registration period of the initial cohort of 5 cases, no major changes shall be made to the device itself, accessory equipment, procedural concept, or primary evaluation methods. If device improvement or procedural modification becomes necessary during the study, it shall be handled separately from this initial cohort after obtaining approval from the ethics committee and other relevant authorities, as necessary.