Gastroesophageal Reflux DiseaseNCT01204931
Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?
An observational study of Gastroesophageal Reflux Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects presenting to Vanderbilt University Medical Center Gastroenterology outpatient clinic with symptoms consistent with gastroesophageal reflux disease (GERD)
Who may be able to join
- Male and female subjects ages 18 or older
- Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
- Undergoing upper endoscopy and wireless pH monitoring (standard of care)
- Erosive disease: presence of esophageal mucosal injuries documented
- Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
- Control group: normal subjects without symptoms of GERD
Who cannot join
- Anti-reflux therapy within 7 days prior to the pH study
- Previous neck, esophagus, or stomach surgery
- Major motility disorders
- Previous neck, esophagus, or stomach cancer or radiations
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center GI Outpatient Clinic
Nashville, Tennessee, 37232
About this study
Official title: Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP
Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- reflux, gastroesophageal reflux disease, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) Cases | Erosive disease - presence of esophageal mucosal injuries documented endoscopically. Non-erosive disease - normal esophagogastroduodenoscopy with symptoms | |
| Control Group | normal subjects without symptoms of gastroesophageal reflux disease (GERD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Index (SI) and Symptom Associated Probability (SAP)
Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)
Measured: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Predicting gastroesophageal reflux disease (GERD)
Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.
Measured: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University
- Investigators
- Michael Vaezi, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204931
- Sponsor's protocol ID
- GERD SISAP
- Status last verified
- Sep 2015
- First submitted
- 13 Sep 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP
- ClinicalTrials.gov ID
- NCT01204931
- Acronym / sponsor ID
- GERD SISAP
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- reflux, gastroesophageal reflux disease, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) Cases | – | –Erosive disease - presence of esophageal mucosal injuries documented endoscopically. Non-erosive disease - normal esophagogastroduodenoscopy with symptoms |
| Control Group | – | –normal subjects without symptoms of gastroesophageal reflux disease (GERD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects presenting to Vanderbilt University Medical Center Gastroenterology outpatient clinic with symptoms consistent with gastroesophageal reflux disease (GERD)
Key inclusion criteria (6 listed)
- Male and female subjects ages 18 or older
- Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
- Undergoing upper endoscopy and wireless pH monitoring (standard of care)
- Erosive disease: presence of esophageal mucosal injuries documented
- Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
Key exclusion criteria (4 listed)
- Anti-reflux therapy within 7 days prior to the pH study
- Previous neck, esophagus, or stomach surgery
- Major motility disorders
- Previous neck, esophagus, or stomach cancer or radiations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Index (SI) and Symptom Associated Probability (SAP)
Time frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)
Predicting gastroesophageal reflux disease (GERD)
Time frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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 Vaezi, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Vanderbilt University 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 6 inclusion and 4 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 20 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom Index (SI) and Symptom Associated Probability (SAP) (time frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring). The study lists 2 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 20 Jan 2016.