Mucosal Impedance in Pediatric Population

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD); Functional Dyspepsia; Eosinophilic Esophagitis (EoE)
• Interventions: Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

• Registration Number: NCT02320981
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-07-14
• Study Start: 2014-08
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EGD with Biopsy	Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance	Pediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance

Primary Outcome Measures

Name	Time	Method
Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE	5 minutes
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)	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.

Trial Locations

Locations (1)

Vanderbilt Children's Hospital; 🇺🇸 Nashville, Tennessee, United States