Esophageal Monitoring Device for Assessing Mucosal Impedance

This study is currently recruiting participants.
Verified July 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01556919
First received: March 12, 2012
Last updated: July 11, 2013
Last verified: July 2013
  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.


Condition Intervention
GERD
Esophagitis
Procedure: Standard of care endoscopy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mucosal Impedance Probe Procedure: Standard of care endoscopy
standard of care endoscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556919

Contacts
Contact: Tina Higginbotham, MPA 615-322-4643 tina.higginbotham@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Endoscopy Laboratory Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tina Higginbotham, MPA    615-322-4643    tina.higginbotham@vanderbilt.edu   
Principal Investigator: Michael F Vaezi, MD, PhD         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01556919     History of Changes
Other Study ID Numbers: 120126
Study First Received: March 12, 2012
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
GERD
Esophagitis

Additional relevant MeSH terms:
Esophagitis
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 16, 2014