Efficacy and safety of a novel ClearHemograsper for gastric endoscopic submucosal dissection: A prospective randomized controlled trial

Abstract

Abstract Endoscopic submucosal dissection (ESD) has become a widely performed procedure for the management of gastric neoplasms. Effective hemostasis during ESD is critical for procedural success and patient safety. This study aimed to evaluate the efficacy and safety of a newly developed hemostatic device, ClearHemograsper, in gastric ESD. Patients who underwent ESD for gastric neoplasms between December 2022 and November 2023 were enrolled and randomly assigned to either the ClearHemograsper group or the Coagrasper group. We conducted a comprehensive analysis of clinicopathologic features and endoscopic treatment outcomes. A total of 157 patients, comprising 80 patients in the ClearHemograsper group and 77 patients in the Coagrasper group, were included in the final analysis. Analyses found no statistically significant differences in the bleeding control time (3.2 ± 2.9 vs. 3.5 ± 2.7 min, 95% Confidence interval, -1.227 to 0.526; p  = 0.430) and total procedure time (15.2 ± 11.8 vs. 15.5 ± 10.4 min, p  = 0.846) between the groups. En bloc resection was successfully performed for all lesions in both groups. Adverse events, including early bleeding (10.0% vs. 3.9%) within 48 h post-procedure and delayed bleeding (0.0% vs. 1.3%), showed no significant differences between the two groups ( p  = 0.211). All adverse events were effectively managed through endoscopic hemostasis. Novel ClearHemograsper demonstrates comparable efficacy and safety to Coagrasper, with preliminary evidence suggesting non-inferior or potentially superior hemostatic performance. These results demonstrate the comparable performance of domestic products in the Korean market, where overseas products occupy the majority of the device market share.