GERD Clinical Trial
Official title:
Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
NCT number | NCT01556919 |
Other study ID # | 120126 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | July 23, 2021 |
Verified date | July 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.
Status | Completed |
Enrollment | 429 |
Est. completion date | July 23, 2021 |
Est. primary completion date | July 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who are undergoing standard of care EGD with or without BRAVO placement; - Have GERD symptoms and/or have endoscopic esophagitis Exclusion Criteria: - Use of acid suppressive therapy within last 10 days; - Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center Endoscopy Laboratory | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mucosal Impedance Values | Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer. | Values will be obtained at conclusion of EGD, an expected average of 5 minutes |
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