Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: single catheter mucosal impedance testing, balloon assembly mucosal impedance testing.
- Who it may be relevant to
- Registry conditions: Gastro Esophageal Reflux. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.
Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.
Interventions
- Diagnostic test single catheter mucosal impedance testing
- Diagnostic test balloon assembly mucosal impedance testing
Primary outcome measures
- mucosal impedance values [Time frame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes]
Eligibility criteria
Inclusion criteria
- Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Vanderbilt University Medical Center Endoscopy Laboratory — Nashville
Publications
- 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 30711626
Identifiers
NCT: NCT03103789 · 140470