Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- The mean impedance
研究概览
简要总结
Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?
详细描述
Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The mean impedance
时间窗: 2 years
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
次要结局
- Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value(2 years)
研究者
Karthik Ravi, M.D.
Principal Investigator
Mayo Clinic