NCT01956877Unknown不适用
Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device
研究概览
简要总结
To assess normal values of EGJ distensibility in healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of gastrointestinal disease, especially gastro-esophageal reflux disease
- •BMI = 18-30 kg/m²
- •Caucasian race
- •Subject signed the informed consent form and is able to adhere to study protocol
排除标准
- •Age < 18 years
- •Previous esophageal or gastric surgery
- •Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy)
- •Patients using anticoagulants
- •Patients unable to give informed consent
- •History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)
结局指标
主要结局
normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device
时间窗: 3 months
EGJ distensibility as measured by the index of the narrowest cross sectional area (mm2) and the corresponding intrabag pressure (mmHg)
次要结局
- Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers.(3 months)
研究者
研究点 (1)
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