We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mucosal Impedance in Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02320981
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : May 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease (GERD) Eosinophilic Esophagitis (EoE) Functional Dyspepsia Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

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 Design

Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
Study Start Date : August 2014
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
EGD with Biopsy
Pediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance
Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE) [ Time Frame: 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.

  2. Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE [ Time Frame: 5 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pediatric patients of our Vanderbilt Pediatric Gastroenterology Clinic undergoing routine evaluation of dyspepsia with endoscopy that meet the inclusion/exclusion criteria as defined above.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320981


Locations
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mary Allyson Lowry, MD Vanderbilt University Medical Center
Principal Investigator: Sari Acra, MD Vanderbilt University Medical Center
Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University Medical Center
More Information

Responsible Party: Michael Vaezi, Co-Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02320981     History of Changes
Other Study ID Numbers: IRB 140987
T32DK007673-21 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael Vaezi, Vanderbilt University Medical Center:
GERD
EGD
pH testing
eosinophilic esophagitis
impedance testing

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Dyspepsia
Eosinophilic Esophagitis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases