bravo: Feasibility of Placing Bravo PH Capsule in Proximal Esophagus

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00378898
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Device: BRAVO capsule; Procedure: Fluoroscopy; Other: sham BRAVO capsule placement	N/A

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

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: DUAL BRAVO PH MONITORING: A Feasibility Trial
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort [48 hours]

Secondary Outcome Measures

1. Subjects Reporting Chest Pain [48 hours]

   Edmonton Symptom Assessment is used to measure the presence and change in symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00378898
• Other Study ID Numbers: 060724
• First Posted: Sep 21, 2006
• Last Update Posted: Apr 4, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

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.

Arm/Group Title	EGD With BRAVO Capsule	EGD With Sham BRAVO Capsule Placement
Arm/Group Description	Bravo PH capsule:egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
Period Title: Overall Study
STARTED	22	17
COMPLETED	11	11
NOT COMPLETED	11	6

Baseline Characteristics

Arm/Group Title	EGD With BRAVO Capsule	EGD With Sham BRAVO Capsule Placement	Total
Arm/Group Description	Bravo PH capsule: egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51	50	51
Sex/Gender, Customized (participants) [Number]
Female	4 36.4%	5 45.5%	9 40.9%
Male	7 63.6%	6 54.5%	13 59.1%
Region of Enrollment (participants) [Number]
United States	11 100%	11 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EGD With BRAVO Capsule	Sham Comparator: EGD With Sham BRAVO Capsule Placement
Arm/Group Description	Bravo PH capsule: egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
Measure Participants	11	11
Number [participants]	2 18.2%	0 0%

2. Secondary Outcome

Title	Subjects Reporting Chest Pain
Description	Edmonton Symptom Assessment is used to measure the presence and change in symptoms.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	EGD With Proximal BRAVO Capsule	EGD With Sham BRAVO Capsule Placement
Arm/Group Description	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. BRAVO capsule Fluoroscopy: one time "xray" to determine evacuation of bravo	Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. sham BRAVO capsule placement
Measure Participants	9	11
Count of Participants [Participants]	6 54.5%	3 27.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGD With BRAVO Capsule, Sham Comparator: EGD With Sham BRAVO Capsule Placement
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.047
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Patients underwent baseline EGD and 48-hour wireless pH monitoring. Assessment of symptoms and any adverse events were completed 48 hours after the study intervention.
Arm/Group Title	EGD With BRAVO Capsule		EGS With Sham BRAVO Capsule Placement
Arm/Group Description	Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study. Fluoroscopy: one time "xray" to determine evacuation of bravo		Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
All Cause Mortality
	EGD With BRAVO Capsule		EGS With Sham BRAVO Capsule Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EGD With BRAVO Capsule		EGS With Sham BRAVO Capsule Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	EGD With BRAVO Capsule		EGS With Sham BRAVO Capsule Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/11 (63.6%)		3/11 (27.3%)
Surgical and medical procedures
Chest pain	7/11 (63.6%)		3/11 (27.3%)

Limitations/Caveats

Selection bias may have been a limitation, as patients volunteering may have had worse symptoms and potentially altered esophageal sensitivity as compared to those who opted not to participate.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.