Development of an Esophageal Monitoring Device for the 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
- 429
- 试验地点
- 1
- 主要终点
- Mucosal Impedance Values
研究概览
简要总结
The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.
详细描述
During routine esophagogastroduodenoscopy (EGD), consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. Each catheter will be manually guided by the physician through the working channel of the endoscope until the sensored tip is visible through the scope camera. The physician will place the sensored rings directly on the mucosa along the lumen. To obtain evaluable data, the sensors must remain in contact with the mucosa at each point for 5 seconds after a stable impedance reading has been captured. This process will be repeated for each of the three prototype catheters in each consented patient in order to determine the optimal catheter/sensor design. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 who are undergoing standard of care EGD with or without BRAVO placement;
- •Have GERD symptoms and/or have endoscopic esophagitis
排除标准
- •Use of acid suppressive therapy within last 10 days;
- •Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
结局指标
主要结局
Mucosal Impedance Values
时间窗: Values will be obtained at conclusion of EGD, an expected average of 5 minutes
Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
次要结局
未报告次要终点
研究者
Michael Vaezi
Medical Director
Vanderbilt University