Immediate Detection of Helicobacter Infection With a New Electrochemical System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
研究概览
简要总结
Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT).
The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.
详细描述
The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Written informed consent
- •Age 18-85 years
- •Ability of subjects to understand character and individual consequences of clinical trial
- •Subjects undergoing EGD
排除标准
- •Inability to provide written informed consent
- •Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- •Pregnancy or breast feeding
- •Active gastrointestinal bleeding
- •Residing in institutions (e.g. prison)
- •PPI intake
- •antibiotic use, actual or within the last 4 weeks
结局指标
主要结局
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
时间窗: Oktober 2009 - February 2011
次要结局
未报告次要终点