Esophageal Monitoring Device for Assessing Mucosal Impedance
Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
1 other identifier
observational
429
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2021
CompletedAugust 3, 2021
July 1, 2021
9.4 years
March 12, 2012
July 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mucosal Impedance Values
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.
Values will be obtained at conclusion of EGD, an expected average of 5 minutes
Study Arms (1)
Mucosal Impedance Probe
Interventions
Eligibility Criteria
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
You may qualify if:
- Patients who are undergoing standard of care EGD with or without BRAVO placement;
- Have GERD symptoms and/or have endoscopic esophagitis
You may not qualify if:
- Use of acid suppressive therapy within last 10 days;
- Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232, United States
Related Publications (1)
Ates F, Yuksel ES, Higginbotham T, Slaughter JC, Mabary J, Kavitt RT, Garrett CG, Francis D, Vaezi MF. Mucosal impedance discriminates GERD from non-GERD conditions. Gastroenterology. 2015 Feb;148(2):334-43. doi: 10.1053/j.gastro.2014.10.010. Epub 2014 Oct 16.
PMID: 25448923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 19, 2012
Study Start
March 1, 2012
Primary Completion
July 23, 2021
Study Completion
July 23, 2021
Last Updated
August 3, 2021
Record last verified: 2021-07