A Randomized Active-controlled Clinical Trial to Investigate the Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) During Endoscopic Resection for Colorectal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hemostasis of intraprocedural bleeding
研究概览
简要总结
The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm
排除标准
- •Pedunculated polyp
- •Patients with coagulopathy
研究组 & 干预措施
The ClearCoajet group
During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding.
干预措施: ClearCoajet (Device)
The control group
During the endoscopic resection procedures, the conventional injector will be used for injection.
干预措施: ClearCoajet (Device)
结局指标
主要结局
Hemostasis of intraprocedural bleeding
时间窗: during endoscopic resection for colorectal lesions
Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions
次要结局
- Delayed bleeding rate(within 4 weeks after endoscopic resection)
- Complication rate(within 4 weeks after endoscopic resection)
研究者
Han Hee Lee
Associate Professor
Yeouido St. Mary's Hospital