Clinical trial NCT03103789: Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Official title: Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastro Esophageal Reflux
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Sandhill Scientific
First posted: 2017-04-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

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

Primary outcomes:
measure: mucosal impedance values
timeFrame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Endoscopy Laboratory
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Vaezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.