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
- 1
- 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
- •Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study.
- •Inclusion criteria:
- •Adults ages 18-90
- •Patients scheduled for or have completed a HRIM ( within 5 days)
- •Patients scheduled for or recently have completed a MII-pH studies ( within 5 days)
- •Patients scheduled for EGD
排除标准
- •Technically limited esophageal HRIM or MII-pH study
- •Patients with HRIM and MII-pH studies not performed within 5 days of each other
- •Patients with EGD not performed within 30 days of HRIM and MII-pH studies
- •Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
- •Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
研究组 & 干预措施
Mucosal Impedance
Patient's having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study.
During the clinical endoscopy, the 2.13 mm catheter will be passed through the channel of the standard endoscope this is called an Intraluminal Impedance. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it.
干预措施: Mucosal Impedance (Device)
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