Back to resultsAssessment of Esophageal Epithelium Integrity With Mucosal Impedance
Primary Purpose
Gastroesophageal Reflux Disease (GERD), Non-erosive Reflux Disease (NERD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease (GERD) focused on measuring reflux, GERD, EGD, pH testing
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
- Previous diagnosis of reflux
- At least 18 years of age
Exclusion Criteria:
- Those less than 18 years of age
- Unable to give informed consent
- Use of acid suppressive therapy within the last 10 days
- Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
GERD
non-GERD
Arm Description
Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Outcomes
Primary Outcome Measures
Measurement of lower esophageal impedance using mucosal impedance catheter
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
Secondary Outcome Measures
Full Information
NCT ID
NCT02318862
First Posted
September 4, 2013
Last Updated
April 27, 2017
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02318862
Brief Title
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
Official Title
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD), Non-erosive Reflux Disease (NERD)
Keywords
reflux, GERD, EGD, pH testing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GERD
Arm Type
Other
Arm Description
Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Arm Title
non-GERD
Arm Type
Other
Arm Description
Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Intervention Type
Procedure
Intervention Name(s)
Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Primary Outcome Measure Information:
Title
Measurement of lower esophageal impedance using mucosal impedance catheter
Description
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
Time Frame
During standard of care EGD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
Previous diagnosis of reflux
At least 18 years of age
Exclusion Criteria:
Those less than 18 years of age
Unable to give informed consent
Use of acid suppressive therapy within the last 10 days
Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vaezi, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
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