NCT02181855Unknown不适用
Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms.
Technical University of Munich8 个研究点 分布在 2 个国家目标入组 23 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Reflux Symptom index
研究概览
简要总结
Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 80 years
- •symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)
排除标准
- •Rejection of study-participation,
- •Pregnancy
- •negative pH-metry / impedance monitoring (non-objectified reflux)
- •hiatal hernia bigger than 2 cm or gastroesophageal junction > Hill IV classification
- •different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus
- •Achalasia, esophageal spasm
- •Presence of contraindications for the interventions
结局指标
主要结局
Reflux Symptom index
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (8)
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