Esophageal Monitoring Device for Assessing Mucosal Impedance

This study is currently recruiting participants.
Verified December 2012 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01556919
First received: March 12, 2012
Last updated: December 19, 2012
Last verified: December 2012

March 12, 2012
December 19, 2012
March 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01556919 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Esophageal Monitoring Device for Assessing Mucosal Impedance
Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With 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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • GERD
  • Esophagitis
Procedure: Standard of care endoscopy
standard of care endoscopy
Experimental: Mucosal Impedance Probe
Intervention: Procedure: Standard of care endoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are undergoing standard of care EDG with BRAVO placement;
  • Have been diagnosed with GERD and 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
Both
18 Years and older
No
Contact: Tina Higginbotham, MPA 615-322-4643 tina.higginbotham@vanderbilt.edu
United States
 
NCT01556919
120126
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Not Provided
Not Provided
Vanderbilt University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP