Feasibility of Placing Bravo PH Capsule in Proximal Esophagus

NCT ID: NCT00378898

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-07-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BRAVO capsule

Intervention Type: DEVICE

Fluoroscopy

Intervention Type: PROCEDURE

one time "xray" to determine evacuation of bravo

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.

Group Type: SHAM_COMPARATOR

sham BRAVO capsule placement

Intervention Type: OTHER

Interventions

BRAVO capsule

Intervention Type: DEVICE

Fluoroscopy

one time "xray" to determine evacuation of bravo

Intervention Type: PROCEDURE

sham BRAVO capsule placement

Intervention Type: OTHER

Other Intervention Names

one time "xray" to determine evacuation of bravo

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Vaezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

The Vanderbilt Clinic/ Endoscopy Lab

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

060724

Identifier Type: -

Identifier Source: org_study_id