[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657827":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":52,"overallOfficials":37,"centralContacts":58,"locations":37,"responsibleParty":64,"collaborators":37,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":37,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":37,"enrollmentInfo":76,"targetDuration":37,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":90,"whyStopped":37,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":37},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of device-related adverse events","The primary endpoint shall be the incidence of device-related adverse events and serious adverse events occurring during the procedure or within 30 days postoperatively.","30 days",[14,18,21,24,27,30,34],{"measure":15,"description":16,"timeFrame":17},"Technical success","The proportion of cases in which the planned defect closure procedure could be performed using the study device according to the intended procedure.","1 day",{"measure":19,"description":20,"timeFrame":17},"Complete closure at the end of the procedure","The proportion of cases in which complete closure was endoscopically achieved at the end of the procedure.",{"measure":22,"description":23,"timeFrame":17},"Closure procedure time","The net time from the start of closure manipulation using the study device until completion of closure or termination of the procedure.",{"measure":25,"description":26,"timeFrame":17},"Number of anchors \u002F suturing elements used","The number of anchors and locks or suturing elements required for closure.",{"measure":28,"description":29,"timeFrame":12},"Need for rescue treatment","The proportion of cases requiring additional treatment using standard closure techniques.",{"measure":31,"description":32,"timeFrame":33},"Maintenance of closure at second-look endoscopy","The proportion of cases in which closure was maintained at the time of second-look endoscopy.","5 day",{"measure":35,"description":36,"timeFrame":12},"Incidence of procedure-related clinical adverse events within 30 days","Incidence of clinically significant postoperative adverse events within 30 days, regardless of causality, including delayed bleeding, delayed perforation, infection, unplanned hospitalization, additional endoscopic treatment, or re-intervention.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","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.\n\nThe 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.\n\nAlthough 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.\n\nBased 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.\n\nAccordingly, 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.",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Su2ura® GI System Group","EXPERIMENTAL","For the gastric defect created after completion of ESD, closure will be attempted using the study device. Anchors shall be placed alternately on both ends of the defect and repeated until the wound is completely closed. The interval between anchors should be aimed at the discretion of the endoscopist, and the anchors should ideally be placed within 5-10 mm from the edge of the defect. If the defect is large and dead space is likely to be formed during closure, additional anchors shall also be placed on the ulcer base so as to eliminate the dead space. The closure procedure shall be performed by an operator who has received appropriate prior training in the use of the device.",[51],"Device: Su2ura® GI system",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":37},"DEVICE","Su2ura® GI system","The Su2ura® O System is a sterile single-use system intended for endoscopic full-thickness approximation of soft tissue through commonly used endoscopic working channels in both the upper and lower gastrointestinal tract.\n\nThe system comprises of 3 sterile single-use parts; (1) a flexible endoscopic suturing device (Su2ura® O Device), (2) magazine pre-loaded with up to 6 threaded (0.30mm UHMWPE Braided Cord) nitinol T-Anchors and (3) a suture lock and thread cutting mechanism (Su2ura® Knot Device); the system is planned to be used through a commonly used endoscopic working channels. Each anchor is deployed by a single trigger operation. The sutures are aimed to be 'full-thickness' and are achieved using threaded nitinol T-anchors with a reduced friction mechanism, which enables fast tightening. The sutures are designed to be widely used by any interventional endoscopists in all endoscopic suites for procedures performed in both the upper and lower gastrointestinal tract.",[47],[59],{"name":60,"role":61,"phone":62,"phoneExt":37,"email":63},"Hon Chi Yip","CONTACT","+852 3505 2956","hcyip@surgery.cuhk.edu.hk",{"type":65,"investigatorFullName":60,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100657827","su2ura-esd-closure-pilot-study-100657827",false,"NCT07843719","Su2ura ESD Closure Pilot Study","The Utility of a Novel Endoscopic Suturing System in Closing Gastrointestinal Defect - a Pilot Human Study","Inclusion Criteria:\n\n* Age 18 years or older\n* Patients scheduled to undergo gastric ESD for gastric epithelial lesions\n* Patients who have received sufficient explanation of this study and from whom written informed consent has been obtained by their own free will\n* Patients judged by the principal investigator or sub-investigator to be appropriate for participation in this study\n\nExclusion Criteria:\n\n* Perforation cases requiring emergency closure\n* Cases with severe coagulation abnormalities, bleeding tendency, or other serious systemic conditions, in whom participation in the study is judged to be inappropriate\n* Cases who are pregnant or may be pregnant\n* Cases in whom obtaining consent for this study is difficult, including minor patients\n* Other cases judged to be inappropriate by the principal investigator or sub-investigator","ALL","18 Years",{"count":77,"type":78},5,"ESTIMATED","INTERVENTIONAL",[39],"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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",[83,84],"ESD Defect","Gastric Epithelial Lesion",[86,87,88,89],"ESD defect","Suturing","gastric lesion","Su2ura® GI System","NOT_YET_RECRUITING","2026-09-22",{"date":93,"type":94},"2026-09-28","ACTUAL",{"date":96,"type":78},"2026-10-01",{"date":98,"type":78},"2028-03-31",{"name":5,"class":6}]