Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Measurement of lower esophageal impedance using mucosal impedance catheter
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
- •Previous diagnosis of reflux
- •At least 18 years of age
排除标准
- •Those less than 18 years of age
- •Unable to give informed consent
- •Use of acid suppressive therapy within the last 10 days
- •Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
研究组 & 干预措施
GERD
Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
干预措施: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing (Procedure)
non-GERD
Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
干预措施: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing (Procedure)
结局指标
主要结局
Measurement of lower esophageal impedance using mucosal impedance catheter
时间窗: During standard of care EGD
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
次要结局
未报告次要终点
研究者
Michael Vaezi
Principal Investigator
Vanderbilt University Medical Center