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Feasibility of Placing Bravo PH Capsule in Proximal Esophagus

DUAL BRAVO PH MONITORING: A Feasibility Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00378898
Acronym
bravo
Enrollment
39
Registered
2006-09-21
Start date
2006-09-30
Completion date
2009-07-31
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

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

DEVICEBRAVO capsule
PROCEDUREFluoroscopy

one time xray to determine evacuation of bravo

OTHERsham BRAVO capsule placement

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort48 hours

Secondary

MeasureTime frameDescription
Subjects Reporting Chest Pain48 hoursEdmonton 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

ArmCount
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
Total22

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation11
Overall StudyWithdrawal by Subject105

Baseline characteristics

CharacteristicEGD With BRAVO CapsuleEGD With Sham BRAVO Capsule PlacementTotal
Age, Continuous51 years50 years51 years
Region of Enrollment
United States
11 participants11 participants22 participants
Sex/Gender, Customized
Female
4 participants5 participants9 participants
Sex/Gender, Customized
Male
7 participants6 participants13 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
7 / 113 / 11
serious
Total, serious adverse events
0 / 110 / 11

Outcome results

Primary

Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort

Time frame: 48 hours

ArmMeasureValue (NUMBER)
EGD With BRAVO CapsulePatients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort2 participants
Sham Comparator: EGD With Sham BRAVO Capsule PlacementPatients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort0 participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EGD With BRAVO CapsuleSubjects Reporting Chest Pain6 Participants
Sham Comparator: EGD With Sham BRAVO Capsule PlacementSubjects Reporting Chest Pain3 Participants
p-value: 0.047t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026