Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318862
• Other study ID #: 130084
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: April 27, 2017
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of lower esophageal impedance using mucosal impedance catheter	Mucosal 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.	During standard of care EGD