Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378898
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2006-09-20
Brief Title:
Feasibility of Placing Bravo PH Capsule in Proximal Esophagus
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
DUAL BRAVO PH MONITORING A Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
bravo
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
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 patients11 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None