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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00388453
First received: October 13, 2006
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
GERD
Larynx Disease
 Device: Dx-pH Probe
Procedure: Manometry
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Data from hypopharyngeal and distal esophageal probe after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • The distance between short catheter probe in the hypopharynx to the upper esophageal sphincter after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Reflux events of hypopharynx and distal esophagus after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • pH data between controls and GERD patients after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Extra-esophageal reflux disease (EERD) patients' symptom improvement at 2 months [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Healthy volunteers with no history of GERD or EERD or PPI use
 Device: Dx-pH Probe
24 hour ph monitoring
Procedure: Manometry
procedure to measure LES and UES
Experimental: 2
subject is known to have GERD based on symptoms and previous positive response to PPI
 Device: Dx-pH Probe
24 hour ph monitoring
Procedure: Manometry
procedure to measure LES and UES
Experimental: 3
subject is known to have EERD based on symptoms and previous positive response to PPI
 Device: Dx-pH Probe
24 hour ph monitoring
Procedure: Manometry
procedure to measure LES and UES

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female volunteers aged 18 to 65 years old.
  2. Control group: No known history of GERD or EERD or prior PPI use.
  3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
  4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion Criteria:

  1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
  2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
  3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
  4. Expected non-compliance.
  5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
  6. Recent nasal surgery or nasal obstruction.
  7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
  8. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388453

Locations
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD, MS Vanderbilt University
  More Information

No publications provided

Responsible Party: Michael F Vaezi, MD, PhD, MS epi, vanderbilt university medical center
ClinicalTrials.gov Identifier: NCT00388453     History of Changes
Other Study ID Numbers: 060860
Study First Received: October 13, 2006
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Healthy volunteers

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngeal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013