NCT06269588招募中不适用
A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- endoscopic hemostasis
研究概览
简要总结
The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore
详细描述
24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged over 21 to 75 years
- •Patients with confirmed nonvariceal, upper gastrointestinal bleeding
- •Patients who voluntarily agree to the clinical trial with informed consent
- •Patients who willing and able to comply with the study protocol
排除标准
- •Patients with an uncorrected coagulation disorder (PLT<50*109/L, INR>2)
- •Patients who are known to be pregnant or in lactation
- •Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
- •Patients for whom endoscopic treatment is prohibited due to comorbidity
- •Patients for whom the 30-day follow-up period is impossible
- •Patients who have participated within the past month in other related clinical trials that could affect the results of the study
- •Other cases in which participation in the study is judged inappropriate by the investigators
研究组 & 干预措施
Endoscopic hemostasis using Nexpowder
Experimental
Subjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment
干预措施: Nexpowder (Device)
结局指标
主要结局
endoscopic hemostasis
时间窗: up to 24 hours
endoscopic hemostasis success rate
次要结局
- recurrent bleeding rate on second-look endoscopy(24 hours)
- hydrogel persistence rate at the bleeding site(24 hours)
- Recurrent bleeding within 30 days after endoscopic therapy(30 days)
研究者
研究点 (2)
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