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Feasibility of Placing Bravo PH Capsule in Proximal Esophagus (bravo)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00378898
First received: September 20, 2006
Last updated: March 31, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Device: BRAVO capsule
Procedure: Fluoroscopy
Other: sham BRAVO capsule placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Diagnostic
Official Title: DUAL BRAVO PH MONITORING: A Feasibility Trial

Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • Subjects Reporting Chest Pain [ Time Frame: 48 hours ]
    Edmonton Symptom Assessment is used to measure the presence and change in symptoms.


Enrollment: 39
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EGD with proximal BRAVO capsule
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.
Device: BRAVO capsule Procedure: Fluoroscopy
one time "xray" to determine evacuation of bravo
Other Name: one time "xray" to determine evacuation of bravo
Sham Comparator: 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.
Other: sham BRAVO capsule placement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378898

Locations
United States, Tennessee
The Vanderbilt Clinic/ Endoscopy Lab
Nashville, Tennessee, United States, 37232-5280
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD Vanderbilt University
  More Information

Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00378898     History of Changes
Other Study ID Numbers: 060724
Study First Received: September 20, 2006
Results First Received: February 26, 2015
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 28, 2017