GERDADHERENCT00388453
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
A study testing Dx-pH Probe and Manometry in people with GERD and Larynx Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD, Larynx Disease
- What is being tested?
- Dx-pH Probe and Manometry
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female volunteers aged 18 to 65 years old.
- Control group: No known history of GERD or EERD or prior PPI use.
- 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.
- EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.
Who cannot join
- 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.
- Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
- Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
- Expected non-compliance.
- Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
- Recent nasal surgery or nasal obstruction.
- 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)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center
Nashville, Tennessee, 37232
About this study
Official title: ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation
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.
Read the 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
- Being tested
- Dx-pH Probe, Manometry
- Keywords
- Healthy volunteers
- Medical subject headings
- Gastroesophageal Reflux, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dx-pH ProbeDevice
24 hour ph monitoring
ManometryProcedure or surgery
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use Receives: Device: Dx-pH Probe; Procedure: Manometry |
| 2 | Experimental | subject is known to have GERD based on symptoms and previous positive response to PPI Receives: Device: Dx-pH Probe; Procedure: Manometry |
| 3 | Experimental | subject is known to have EERD based on symptoms and previous positive response to PPI Receives: Device: Dx-pH Probe; Procedure: Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in pH From Baseline to <4
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
Measured: 24 hours
Decrease in pH From Baseline to <5
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
Measured: 24 hours
Decrease in pH From Baseline to <6
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
Measured: 24 hours
Secondary outcomes (1)
Number of Reflux Events
Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University Medical Center
- Investigators
- Michael F Vaezi, MD, PhD, MS, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388453
- Sponsor's protocol ID
- 060860
- Acronym
- ADHERE
- Status last verified
- May 2017
- First submitted
- 13 Oct 2006
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation
- ClinicalTrials.gov ID
- NCT00388453
- Acronym / sponsor ID
- ADHERE / 060860
- Conditions
- GERD, Larynx Disease
- Keywords
- Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Oct 2006 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Dx-pH Probe, Procedure: ManometryHealthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use |
| 2 | Experimental | Device: Dx-pH Probe, Procedure: Manometrysubject is known to have GERD based on symptoms and previous positive response to PPI |
| 3 | Experimental | Device: Dx-pH Probe, Procedure: Manometrysubject is known to have EERD based on symptoms and previous positive response to PPI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female volunteers aged 18 to 65 years old.
- Control group: No known history of GERD or EERD or prior PPI use.
- 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.
- EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.
Key exclusion criteria (8 listed)
- 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.
- Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
- Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
- Expected non-compliance.
- Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dx-pH Probe24 hour ph monitoring | Device | 1, 2, 3 |
| Manometryprocedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES) | Procedure or surgery | 1, 2, 3 |
Primary outcome
Decrease in pH From Baseline to <4
Time frame: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
Decrease in pH From Baseline to <5
Time frame: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
Decrease in pH From Baseline to <6
Time frame: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
1 secondary outcome
Number of Reflux Events
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Vaezi, MD, PhD, MS principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dx-pH Probe and Manometry in people with GERD and Larynx Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in pH From Baseline to <4 (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.