A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Recurrent bleeding rate
研究概览
简要总结
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.
详细描述
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR
排除标准
- •Coagulation disorder (PLT < 50*10^9/L, INR > 2)
- •Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy
研究组 & 干预措施
UI-EWD Hemostatic system
Patients with upper gastrointestinal bleeding treated with UI-EWD
干预措施: UI-EWD Hemostatic system (Device)
epinephrine
Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection
干预措施: epinephrine endoscopic injection (conventional therapy) (Drug)
结局指标
主要结局
Recurrent bleeding rate
时间窗: 3 days
Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin \> 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.
次要结局
未报告次要终点