NCT04406116Unknown不适用
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument for Actual or Potential Non-variceal Bleeding in the Upper Gastrointestinal (GI) Tract
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
研究概览
简要总结
Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or authorised representative able to comprehend and sign the Informed Consent form.
- •Actual or potential non-variceal bleeding in the upper GI, including angiodysplasia or AVM malformations such as Dieulafoy's lesion with a Glasgow-Blatchford score of greater than 1
排除标准
- •As stated in the contraindications in the HS1 IFU;
- •Aged <18 years of age
- •Those described as vulnerable populations in EN ISO 14155;
- •Patients with a known coagulopathy (congenital);
- •Concurrent participation in another experimental intervention or drug study
- •Unwilling or unable to provide informed consent.
- •A patient whose Glasgow-Blatchford score is 1 or less
研究组 & 干预措施
patients receiving microwave therapy using the HS1 Instrument
Experimental
干预措施: Microwave coagulation using HS1 Instrument (Device)
结局指标
主要结局
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
时间窗: Perioperative
Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.
次要结局
- Identification and incidence of intra-procedural complications(Day 0)
- Identification and incidence of post-procedural complications(At 24-72 hours, 1 week and 4 weeks)
- Change in Glasgow-Blatchford score(Day 0 for initial screen and then 24-72 hours post-procedure for second score.)
研究者
研究点 (1)
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