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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02318862
Other study ID # 130084
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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