Status:
COMPLETED
Feasibility of Placing Bravo PH Capsule in Proximal Esophagus
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Assessing the feasibility and patient tolerance to placement of Bravo PH capsule in proximal esophagus. There will be no difference in patient-perception of a proximally-placed Bravo esophageal pH mo...
Detailed Description
24-hour pH monitoring is often considered the "gold standard" in the diagnosis of GERD and is increasingly utilized in patients with extra-esophageal symptoms (1). However, the clinical utility of pH ...
Eligibility Criteria
Inclusion
- Inclusion criteria will include the following:
- Patients greater than or equal to 18 years of age
- Patients having regularly scheduled upper endoscopy with planned Bravo pH monitor testing
- Patients with known GERD based on symptoms (heartburn, regurgitation) and response to a proton pump inhibitor or esophagitis on EGD as well as those with extraesophageal GERD (cough, asthma and throat discomfort).
Exclusion
- Exclusion criteria will include the following:
- Previous surgical procedures to the upper esophagus
- History of bleeding diathesis or coagulopathy
- Stroke or transient ischemic attack within the past 6 months
- GI bleeding within the previous 6 months
- Known esophageal varices
- Significant medical illness (i.e., congestive heart failure)
- Pregnancy
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00378898
Start Date
September 1 2006
End Date
July 1 2009
Last Update
April 4 2017
Active Locations (1)
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1
The Vanderbilt Clinic/ Endoscopy Lab
Nashville, Tennessee, United States, 37232-5280