Esophageal Monitoring Device for Assessing Mucosal Impedance

Vanderbilt University429 enrolled

Overview

The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.

During routine esophagogastroduodenoscopy (EGD), consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. Each catheter will be manually guided by the physician through the working channel of the endoscope until the sensored tip is visible through the scope camera. The physician will place the sensored rings directly on the mucosa along the lumen. To obtain evaluable data, the sensors must remain in contact with the mucosa at each point for 5 seconds after a stable impedance reading has been captured. This process will be repeated for each of the three prototype catheters in each consented patient in order to determine the optimal catheter/sensor design. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.

Study Type

OBSERVATIONAL

Enrollment

429

Conditions

GERD Esophagitis

Interventions

Standard of care endoscopyPROCEDURE

standard of care endoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are undergoing standard of care EGD with or without BRAVO placement; * Have GERD symptoms and/or have endoscopic esophagitis Exclusion Criteria: * Use of acid suppressive therapy within last 10 days; * Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition

Locations (1)

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Mucosal Impedance Values

Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.

Time frame: Values will be obtained at conclusion of EGD, an expected average of 5 minutes

Data from ClinicalTrials.gov

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