Multicenter, single-blind (subject), active control comparison, randomization, non-inferiority, sponsor Initiated Trials to confirm the hemostatic effect and safety of 'CEGP003' in patients with bleeding during hemorrhagic non-variceal upper gastrointestinal bleeding procedure

CGBio0 个研究点目标入组 218 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•1. A man or woman 19 years of age or older
•2. Peptic ulcers or active bleeding after EMR or ESD procedures, or high risk of rebleeding (non-bleeding visible vessels).
•3. Those who are willing to participate in the examination, to follow treatments and procedures, and to visit the hospital for all observational evaluations
•4. Person who voluntarily signed written consent after explaining the purpose and method of this study

•[Checked at the time of screening]
•1. Subject with uncorrected coagulation disorder(PLT <50 * 103 / µL, INR> 2)
•2. Subject who cannot stop taking antiplatelet drugs or anticoagulants except aspirin for the treatment
•3. Pregnant or lactating women
•4. Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
•5. Subjects who have undergone endoscopically therapies within the last 7 days
•6. Subjects who are contraindicated for endoscopic treatment due to accompanying diseases
•7. Subjects who are Participants in other interventions that may affect clinical trial results within the last three months
•8. Subjects who is determined to be ineligible for participation in this clinical trial based on other investigator's judgment.
•[Checked on the day of endoscopy procedure]
•9. Subjects who Endoscopic findings that do not correspond to Ia ~ IIb according to the Forrest classification method and that the bleeding pattern cannot be treated with a test device or a control device

发起方

CGBio