Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Mucosal Impedance Probe
  • Procedure: Standard of care endoscopy
    standard of care endoscopy

Recruiting Locations

Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee 37232
Contact:
Tina Higginbotham, MPA
615-322-4643
tina.higginbotham@vumc.org

More Details

NCT ID
NCT01556919
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Tina Higginbotham, MPA
615-322-4643
tina.higginbotham@vumc.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.