Mucosal Impedance in Pediatric Population

NCT02320981 | Completed DMC

• 2 other identifiers: IRB 140987T32DK007673-21
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Eosinophilic Esophagitis (EoE); Functional Dyspepsia

Keywords

GERD; EGD; pH testing; eosinophilic esophagitis; impedance testing

Outcome Measures

Primary Outcomes (2)

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

  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.

  5 minutes

• Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE

  5 minutes

Study Arms (1)

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

Interventions

Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance DIAGNOSTIC_TEST

EGD with Biopsy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Eosinophilic Esophagitis

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: December 19, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)