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Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02318862
Enrollment
15
Registered
2014-12-17
Start date
2013-07-01
Completion date
2016-12-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease (GERD), Non-erosive Reflux Disease (NERD)

Keywords

reflux, GERD, EGD, pH testing

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.

Interventions

PROCEDUREStandard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of lower esophageal impedance using mucosal impedance catheterDuring standard of care EGDMucosal 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael Vaezi, MD, PhD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026