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

• Conditions: Gastro Esophageal Reflux
• Interventions: Diagnostic Test: single catheter mucosal impedance testing; Diagnostic Test: balloon assembly mucosal impedance testing

• Registration Number: NCT03103789
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.

Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.

Study Timeline

• Study Start: 2014-04-29
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement

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Exclusion Criteria

• Age less than 18 years old
• Patients unable to give informed consent
• Use of acid suppressive therapy within last 10 days
• Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GERD patients	balloon assembly mucosal impedance testing	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.
GERD patients	single catheter mucosal impedance testing	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.
control	single catheter mucosal impedance testing	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.
control	balloon assembly mucosal impedance testing	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 Measures

Name	Time	Method
mucosal impedance values	Values will be obtained at conclusion of EGD, an expected average of 6 minutes	compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls

Trial Locations

Locations (1)

Vanderbilt University Medical Center Endoscopy Laboratory; 🇺🇸 Nashville, Tennessee, United States