Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
1 other identifier
observational
75
1 country
1
Brief Summary
The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 21, 2025
May 1, 2025
12.3 years
March 31, 2017
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
mucosal impedance values
compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls
Values will be obtained at conclusion of EGD, an expected average of 6 minutes
Study Arms (2)
GERD patients
Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly.
control
Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly.
Interventions
Eligibility Criteria
Patients who are scheduled for endoscopic procedures (esophagogastroduodenoscopy (EGD)) by the principal investigator as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study.
You may qualify if:
- Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement
You may not qualify if:
- Age less than 18 years old
- Patients unable to give informed consent
- Use of acid suppressive therapy within last 10 days
- Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Sandhill Scientificcollaborator
Study Sites (1)
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232, United States
Related Publications (1)
Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.
PMID: 30711626DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Vaezi, MD, PhD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 6, 2017
Study Start
April 29, 2014
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share