A Prospective, Multicenter, Open-label, Randomized Controlled Study to Evaluate Safety and Effectiveness of Endoscopic Hemostatic Powder, 'Nexpowder' for Hemostatic Treatments of Lower Gastrointestinal Bleeding After Colon Polypectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
研究概览
简要总结
In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.
详细描述
Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult volunteers aged 19 or older during screening
- •A person who is scheduled to perform polypectomy for polyps with a diameter of 2 cm or more, such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)
- •If the researcher agrees to voluntarily participate in the clinical study and determines that the subject cannot voluntarily consent due to the elderly aged 80 or older or other emergency situations, a written consent of the subject's legal representative is required
排除标准
- •Upper gastrointestinal bleeding
- •If ulcerative bleeding is not caused by the procedure
- •If you are suffering from a blood clotting disorder
- •Aspirin and anticoagulant medications cannot be discontinued
- •Pregnant or lactating
- •Where colonoscopy is prohibited due to comorbid diseases, etc
- •If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope
- •If you have participated in a relevant clinical trial that may affect the results of this study within the last one month
- •Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
- •A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies
- •In the case where the researcher determines that it is inappropriate to participate in clinical trials due to other reasons other than the above selection exclusion criteria
研究组 & 干预措施
Conventional Treatment
Conventional Treatment
干预措施: Conventional Treatment (Procedure)
Conventional Treatment + Nexpowder
Conventional Treatment + Nexpowder
干预措施: Nexpowder (Device)
结局指标
主要结局
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
时间窗: 30 days
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Rate of rebleeding within 7 days of successful endoscopic hemostasis
时间窗: 7 days
Rate of rebleeding within 7 days of successful endoscopic hemostasis
次要结局
- Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group(5 min)
- Number of Nexpowder applications (experimental group)(7 days)
- Rate of ease of use (experimental group)(7 days)
- Death rate(7 days)
- Blood transfusion case rate(7 days)
- Perforation incidence(7 days)
- Number of usage of Nexpowder (experimental group)(7 days)
- Incidence of device malfunction (experimental group)(7 days)