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Esophageal Monitoring Device for Assessing Mucosal Impedance

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Michael Vaezi, Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01556919
First received: March 12, 2012
Last updated: May 10, 2017
Last verified: May 2017
  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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 Michael Vaezi, Vanderbilt University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 750
Study Start Date: March 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for an esophagogastroduodenoscoy (EGD) for one of the following reasons: diagnosed with Gastroesophegeal reflux disease (GERD); have a normal esophageal mucosa but an abnormal pH testing (acid measurement); or a normal esophagus and normal pH testing
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 10, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Vaezi, Vanderbilt University:
GERD
Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on June 22, 2017