A prospective, single-center (subject), single-blind, randomized, confirmatory clinical trial was conducted to compare and evaluate the effectiveness and safety of absorbable internal hemostatic products used for hemostasis of oozing in patients with upper gastrointestinal ulcer bleeding due to endoscopic mucosal resection or endoscopic sub-mucosal dissection compared with 'argon plasma coagulation'

¦Effectiveness evaluation results The effectiveness evaluation was conducted on FAS and PPS, and the final effectiveness evaluation was conducted on FAS, the main analysis group. FAS included all 76 subjects registered in this clinical trial, and no major violations of the clinical trial protocol were identified, but 72 subjects, excluding 4 who failed to complete this clinical trial and dropped out, were included in PPS. As a result of the analysis of the primary efficacy endpoint, the initial hemostasis rate (proportion of subjects whose exudative bleeding completely stopped within 5 minutes after attempting hemostasis), the test group was 97.37% (successful in 37 out of 38 patients) and the control group was 97.37% (38 patients). There was no difference in the rate between the test group and the control group, and the lower limit of the 97.5% one-sided confidence interval for this was -8.23%, which was higher than the non-inferiority limit of -15.0%, indicating that the test group had a higher clinical benefit than the control group. It has been proven that it is not inferior. The secondary efficacy endpoint, rebleeding rate (proportion of subjects who experienced rebleeding at the hemostasis treatment site), was 0.00% for both the test and control groups, and no rebleeding occurred in any of the subjects. Healing success rate (proportion of the number of subjects classified as scarring stage (S1 or S2) according to Sakita classification and complete healing) was assessed at 1 day after the procedure: 2.70% in the test group and 0.00% in the control group; At 30 days after the procedure, the test group had a high healing success rate of 88.57% in the test group and 78.38% in the control group at both time points, but no statistically significant difference was observed between groups. ¦ Safety evaluation results As a result of the safety evaluation, the total number of subjects who experienced an adverse event at least once was 22 (28.95%), with 11 (28.95%) in the test group and 11 (28.95%) in the control group, so the test and control groups were the same. All of the reported adverse events were mild or moderate in severity and, except for one adverse event in the control group, which was assessed as having little relevance to the investigational medical device, all were not related to the investigational medical device. Most subjects received medication and/or procedures to treat adverse events, and it was confirmed that all subjects had recovered or were recovering without any aftereffects. Additionally, no deaths occurred, and no subjects experienced serious adverse events. There was no statistically significant difference between groups in all vital sign test items (body temperature, systolic and diastolic blood pressure, pulse), and in the case of average change in body temperature, there was a statistically significant difference between groups at visit 4, but at all visit points. Changed within the normal body temperature range. There was no statistically significant difference between groups in the average change in systolic and diastolic blood pressure in all items at all time points, and the average change in pulse rate showed a statistically significant difference between groups at visit 3, but was normal at all visit points. The pulse varied within the range. Other than this, there was no statistically significant difference between groups in the amount of change in vital signs.