Su2ura ESD Closure Pilot Study

ESD Defect, Gastric Epithelial Lesion

ESD defect, Suturing, gastric lesion, Su2ura® GI System

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.

Endoscopic suturing platforms are expected to have future applications in more advanced interventional settings, including closure of full-thickness defects, treatment of perforations and fistulas, management of post-resection defects, and bariatric endoscopy. Full-thickness suturing may offer theoretical advantages for larger or deeper defects that are difficult to manage with conventional clip-based methods. At the same time, currently available devices still have important limitations, including technical complexity, restricted maneuverability, and cumbersome setup. For this reason, development of a simpler through-the-scope suturing platform is clinically meaningful. The Su2ura® GI System was developed as a novel through-the-scope full-thickness endoscopic suturing platform. In preclinical animal experiments, it showed feasibility through a standard endoscopic working channel, a relatively short learning curve, successful full-thickness tissue capture, and acceptable histologic tissue response. The device has demonstrated significant potential as a robust suturing device that could be applied in a number of clinical settings owing to its simplicity in use. Human use of Su2ura® GI system has not yet been reported. Although the clinical settings in which this device may ultimately be used included full-thickness defects, perforations, fistulas, and bariatric interventions, these are all relatively high-risk situations with considerable risks when adverse event occurs. When introducing a novel device or procedure into clinical practice, it is important not to begin directly in the highest-risk indication, but instead to first establish proof of principle and initial safety in a controlled and predictable setting. The IDEAL framework recommends staged evaluation of new procedures and devices, beginning with small prospective series and emphasizing prospective registration, sequential reporting, and transparent documentation of technical development. Similarly, the FDA guidance on early feasibility studies describes such studies as small clinical investigations intended to obtain proof of principle and initial clinical safety data when nonclinical testing alone is not sufficient to support further development. Based on the above rationale, closure of post-ESD gastric defects was selected as the target clinical setting for first-in-human study. Post-ESD gastric defects provide a suitable setting for this purpose because they are created during a planned procedure, the location and extent of the defect can be assessed directly during the intervention, and established rescue options remain available if suturing is incomplete or unsuccessful. Compared with true full-thickness defects or perforation cases, this setting is therefore associated with a lower incremental risk when introducing a novel suturing device into human use. Several methods have been described for closure of gastric post-ESD defects, but each has its own advantages and limitations, and no single method has been established as optimal in all situations. Therefore, post-ESD gastric defects should not be regarded as the final target indication of this device, but rather as a controlled clinical entry model in which its basic operability and short-term safety can be assessed in humans before moving to more complex and higher-risk applications. Accordingly, the purpose of this study is not to demonstrate superiority over existing closure methods or to establish the value of routine closure after gastric ESD. Rather, this study is designed to evaluate the short-term safety and procedural feasibility of a novel through-the-scope full-thickness suturing system under conditions that provide the greatest degree of patient protection for initial human use.

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