Esophageal Monitoring Device for Assessing Mucosal Impedance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Conditions
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GERD, Esophagitis

Intervention / Treatment
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* Procedure: Standard of care endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mucosal Impedance Probe<br> | Procedure: Standard of care endoscopy<br>* standard of care endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Values will be obtained at conclusion of EGD, an expected average of 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Esophagitis