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Completed

NCT Number: NCT01556919

Esophageal Monitoring Device for Assessing Mucosal Impedance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care endoscopy

Procedure

standard of care endoscopy

Primary outcomes

  1. Mucosal Impedance Values

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

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2012
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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