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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance|
- Mucosal Impedance Values [ Time Frame: Values will be obtained at conclusion of EGD, an expected average of 5 minutes ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Mucosal Impedance Probe||
Procedure: Standard of care endoscopy
standard of care endoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556919
|Contact: Tina Higginbotham, MPAemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center Endoscopy Laboratory||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Tina Higginbotham, MPA 615-322-4643 firstname.lastname@example.org|
|Principal Investigator: Michael F Vaezi, MD, PhD|