NCT00388453

Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease

ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Detailed description

Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.

Conditions

• GERD
• Larynx Disease

Interventions

Type	Name	Description
DEVICE	Dx-pH Probe	24 hour ph monitoring
PROCEDURE	Manometry	procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-09-01
• Completion: 2013-07-01
• First posted: 2006-10-16
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

1 site across 1 country: United States