Safety Study of Su2uraAE GI System for Endoscopic Suturing After Gastric Lesion Removal by EMR or ESD

What this Trial Is About

Researchers are evaluating the safety of the Su2ura4 GI system for endoscopic suturing and soft-tissue closure in patients undergoing endoscopic mucosal resection EMR or endoscopic submucosal dissection ESD of gastric neoplastic lesions. This prospective, open-label study aims to measure rates of incomplete closure, bleeding, infection, leakage, and adverse device effects within specific timeframes after the procedure. Up to 25 patients will be recruited for this single-center study. Participants will undergo tissue resection by EMR or ESD, followed immediately by endoscopic suturing using the Su2ura4 GI system. The device is inserted through the gastroscope to grasp tissue and deploy full-thickness anchors in a controlled pattern, securing the suture with a knot device. The procedure is followed by a typical recovery with an expected one-night hospital stay and discharge the next day. The study includes six visits screening, baselinesurgery day, discharge with 4-week, 3-month, and 6-month post-surgery follow-ups. During the study, patients will have physical exams, vital sign checks, blood tests, and quality of life questionnaires at regular intervals. A gastroscopy will be performed around 28 days post-procedure to check for local recurrence. Researchers will closely monitor safety outcomes including adverse device effects and serious events up to 6 months. Total participation time for each patient is up to about 6.5 months, with careful observation throughout the recovery and follow-up periods.

Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System