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Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
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.
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.
Age
1 - 18 years
Sex
ALL
Healthy Volunteers
Yes
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Start Date
August 1, 2014
Primary Completion Date
September 1, 2016
Completion Date
September 1, 2016
Last Updated
May 1, 2017
127
ACTUAL participants
Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance
DIAGNOSTIC_TEST
Lead Sponsor
Vanderbilt University Medical Center
Collaborators
NCT06693531
NCT07182890
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07196735