Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GERD

Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Group Type OTHER

Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Intervention Type PROCEDURE

non-GERD

Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Group Type OTHER

Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Intervention Type PROCEDURE

Interventions

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Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No