Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03103789
Status
Enrolling By Invitation

Conditions

  • Gastro Esophageal Reflux

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • single catheter mucosal impedance testing — DIAGNOSTIC_TEST
  • balloon assembly mucosal impedance testing — DIAGNOSTIC_TEST

Study Details

The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

Key Dates

Start date
Apr 29, 2014
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: GERD patients
    Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly.
  • Arm: control
    Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly.

Primary Outcome Measure

mucosal impedance values [ Time Frame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical Center Endoscopy LaboratoryNashvilleTennessee37232-

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By research site
Vanderbilt University Medical Center Endoscopy Laboratory· Nashville, TN

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