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临床试验/NCT02320981
NCT02320981已完成不适用

Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)

研究概览

简要总结

Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.

详细描述

The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 1 year and 18 years of age
  • Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia

排除标准

  • Families unable to give informed consent/assent;
  • Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions

结局指标

主要结局

Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)

时间窗: 5 minutes

Mucosal impedance will be obtained during standard of care endoscopy and results will be available immediately. For those patients who may be undergoing ph monitoring as standard of care, those data will be compared to the mucosal impedance values obtained at bedside.

Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE

时间窗: 5 minutes

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

Co-Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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Mucosal Impedance in Pediatric Population | 临床试验