Gastroesophageal Reflux Disease
Conditions
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 monitor compared with a distal monitor.
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 monitoring in this patient population remains controversial. An important limitation of traditional pH catheters is their suboptimal sensitivity especially in patients with extraesophageal GERD. Vaezi et al. tested reproducibility and reliability of the proximal and distal esophageal pH probe in 32 patients (2). Among these patients,11 were controls, 10 had distal reflux, and 11 had both proximal and distal reflux. In this group of patients the sensitivity of distal and proximal pH probes were 70% and 55%, respectively. Additionally, a more recent study by Shaker et al. showed the number and duration of hypopharyngeal reflux events to be similar between the control subjects and patients with reflux laryngitis and vasomotor rhinitis (3). Poor sensitivity of catheter based pH monitoring in detecting acid reflux may be due to day to day variability of test, its less than adequate reliability as well as possible intermittent nature of the reflux events (not recorded in only a 24-hour period) (4). Additionally, since the traditional ambulatory device is commonly placed transnasally through the oropharynx into the esophagus, patients often complain of throat and nose discomfort and usually restrict their daily activity. This potentially leads to false negative findings and reduced test sensitivity. Furthermore, incorrect results may be collected if the pH electrode slips away from the initial manometrically determined placement site. In light of these limitations, a new wireless (catheter free) pH monitoring device was developed to improve patient comfort and increase test sensitivity. The Bravo pH monitoring system (Medtronic Inc, Minneapolis, MN) uses a radiotelemetric capsule temporarily attached to the esophageal mucosa which transmits pH data to a receiver carried on patient's belt. Although well studied in the distal esophagus, there are currently no studies in adults assessing the feasibility and patient tolerance to placement of this device more proximally. Such a placement may increase the sensitivity of the test and add to our ability to study potential predictors of treatment response in patients with extraesophageal GERD.
Interventions
one time xray to determine evacuation of bravo
Sponsors
Study design
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
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort | 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Reporting Chest Pain | 48 hours | Edmonton Symptom Assessment is used to measure the presence and change in symptoms. |
Countries
United States
Participant flow
Recruitment details
Subjects were 18 years of age or older and scheduled for esophagogastroduodenoscopy (EGD) and wireless pH testing for physiologic assessment of esophageal acid exposure for typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and regurgitation or for extra-esophageal reflux symptoms such as cough or asthma at Vanderbilt.
Participants by arm
| Arm | Count |
|---|---|
| EGD With BRAVO Capsule Bravo PH capsule: egd with bravo placement
Fluoroscopy: one time xray to determine evacuation of bravo | 11 |
| EGD With Sham BRAVO Capsule Placement Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 5 |
Baseline characteristics
| Characteristic | EGD With BRAVO Capsule | EGD With Sham BRAVO Capsule Placement | Total |
|---|---|---|---|
| Age, Continuous | 51 years | 50 years | 51 years |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex/Gender, Customized Female | 4 participants | 5 participants | 9 participants |
| Sex/Gender, Customized Male | 7 participants | 6 participants | 13 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 11 | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EGD With BRAVO Capsule | Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort | 2 participants |
| Sham Comparator: EGD With Sham BRAVO Capsule Placement | Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort | 0 participants |
Subjects Reporting Chest Pain
Edmonton Symptom Assessment is used to measure the presence and change in symptoms.
Time frame: 48 hours
Population: 2 subjects had to have the BRAVO removed before 48 hours due to reported discomfort in the BRAVO placement group so chest pain scores were obtained for 9 of the 11 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGD With BRAVO Capsule | Subjects Reporting Chest Pain | 6 Participants |
| Sham Comparator: EGD With Sham BRAVO Capsule Placement | Subjects Reporting Chest Pain | 3 Participants |