Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Vanderbilt University Medical Center

Status: Completed

Conditions: Non-erosive Reflux Disease (NERD); Gastroesophageal Reflux Disease (GERD)

Treatments: Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02318862

130084

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

GERD

Other group

Description:

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

Treatment:

Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

non-GERD

Other group

Description:

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

Treatment:

Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing