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临床试验/NCT03103789
NCT03103789Enrolling By Invitation不适用

Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
75
试验地点
2
主要终点
mucosal impedance values

研究概览

简要总结

The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

详细描述

During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.

Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement

排除标准

  • Age less than 18 years old
  • Patients unable to give informed consent
  • Use of acid suppressive therapy within last 10 days
  • Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication

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 6 minutes

compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vaezi

Principal Investigator

Vanderbilt University Medical Center

研究点 (2)

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