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
ClinicalTrials.gov Identifier:
NCT00378898
First received: September 20, 2006
Last updated: July 11, 2013
Last verified: July 2013
  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 Phase
Gastroesophageal Reflux Disease
Device: Bravo PH capsule
Procedure: Fluoroscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: DUAL BRAVO PH MONITORING: A Feasibility Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Patient tolerance to a Bravo PH monitor in the proximal esophagus after 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collection of and comparison of data between distal and proximal Bravo capsule [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 25
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
EGD with BRAVO capsule Device: Bravo PH capsule
standard of care egd with bravo placement
Other Name: standard of care esophagogastroduodenoscopy with bravo placement
Procedure: Fluoroscopy
one time "xray" to determine evacuation of bravo
Other Name: one time "xray" to determine evacuation of bravo

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
Genders Eligible for Study:   Both
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
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD, MS epi Vanderbilt University
  More Information

No publications provided

Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00378898     History of Changes
Other Study ID Numbers: 060724
Study First Received: September 20, 2006
Last Updated: July 11, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 22, 2014