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View Clinical Trial (Medical Research Study)
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Efficacy of Dx-pH Probe in Diagnosing Extra-Esophageal Reflux Disease - NCT00388453-37232 (Clinical Trial 152921)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy152921.aspx
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| City: |
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Nashville |
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State:
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TN |
| Zip Code: |
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37232 |
| Conditions: |
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GERD - Larynx Disease |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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December 29, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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