Gastroesophageal Reflux Disease Clinical Trial
— bravoOfficial title:
DUAL BRAVO PH MONITORING: A Feasibility Trial
Verified date | March 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
monitor compared with a distal monitor.
Status | Completed |
Enrollment | 39 |
Est. completion date | July 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Vanderbilt Clinic/ Endoscopy Lab | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort | 48 hours | ||
Secondary | Subjects Reporting Chest Pain | Edmonton Symptom Assessment is used to measure the presence and change in symptoms. | 48 hours |
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