Gastroesophageal Reflux DiseasebravoNCT00378898
Feasibility of Placing Bravo PH Capsule in Proximal Esophagus
A study testing BRAVO capsule and Fluoroscopy in people with Gastroesophageal Reflux Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- BRAVO capsule and Fluoroscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Vanderbilt Clinic/ Endoscopy Lab
Nashville, Tennessee, 37232-5280
About this study
Official title: DUAL BRAVO PH MONITORING: A Feasibility Trial
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- BRAVO capsule, Fluoroscopy, sham BRAVO capsule placement
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAVO capsuleDevice
FluoroscopyProcedure or surgery
Also called one time "xray" to determine evacuation of bravo
one time "xray" to determine evacuation of bravo
sham BRAVO capsule placementOther
| Study group | Role | What they receive |
|---|---|---|
| EGD with proximal BRAVO capsule | Active comparator | Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment. Receives: Device: BRAVO capsule; Procedure: Fluoroscopy |
| EGD with sham BRAVO capsule placement | Sham comparator | Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Receives: Other: sham BRAVO capsule placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort
Measured: 48 hours
Secondary outcomes (1)
Subjects Reporting Chest Pain
Edmonton Symptom Assessment is used to measure the presence and change in symptoms.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University Medical Center
- Investigators
- Michael F Vaezi, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378898
- Sponsor's protocol ID
- 060724
- Acronym
- bravo
- Status last verified
- Mar 2017
- First submitted
- 20 Sep 2006
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUAL BRAVO PH MONITORING: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT00378898
- Acronym / sponsor ID
- bravo / 060724
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD with proximal BRAVO capsule | Active comparator | Device: BRAVO capsule, Procedure: FluoroscopySubjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment. |
| EGD with sham BRAVO capsule placement | Sham comparator | Other: sham BRAVO capsule placementSubjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRAVO capsule | Device | EGD with proximal BRAVO capsule |
| FluoroscopyAlso: one time "xray" to determine evacuation of bravoone time "xray" to determine evacuation of bravo | Procedure or surgery | EGD with proximal BRAVO capsule |
| sham BRAVO capsule placement | Other | EGD with sham BRAVO capsule placement |
Primary outcome
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort
Time frame: 48 hours
1 secondary outcome
Subjects Reporting Chest Pain
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Vaezi, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRAVO capsule and Fluoroscopy in people with Gastroesophageal Reflux Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.