NCT02688699尚未招募4 期
Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
University of Turin, Italy0 个研究点目标入组 288 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 288
- 主要终点
- effectiveness of EndoClotTM in preventing post-procedural bleeding
研究概览
简要总结
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •lesions suitable for EMR or ESD
- •site in the right colon
排除标准
- •Severe cardiovascular pathologies
- •Liver and Urinary dysfunctions
- •Hematologic diseases
- •Pregnancy and breast feeding
- •impossible follow-up
- •platelet and coagulation disorders (PLT < 50 x 109/L, INR > 2)
- •Sensitivity or allergy to the drug
研究组 & 干预措施
control
No Intervention
EndoClot
Experimental
spraying of Endoclot powder after EMR or ESD
干预措施: EndoClot (Procedure)
结局指标
主要结局
effectiveness of EndoClotTM in preventing post-procedural bleeding
时间窗: 14 days
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon
次要结局
未报告次要终点
研究者
Alberto Arezzo
Associate Professor of Surgery, MD
University of Turin, Italy
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