Gastroesophageal Reflux Disease (GERD)NCT02318862
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
A study of Gastroesophageal Reflux Disease (GERD) and Non-erosive Reflux Disease (NERD), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Non-erosive Reflux Disease (NERD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
- Previous diagnosis of reflux
- At least 18 years of age
Who cannot join
- Those less than 18 years of age
- Unable to give informed consent
- Use of acid suppressive therapy within the last 10 days
- Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.
- Being tested
- Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
- Keywords
- reflux, GERD, EGD, pH testing
- Medical subject headings
- Gastroesophageal Reflux, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| GERD | Other | Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing Receives: Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing |
| non-GERD | Other | Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing Receives: Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lower esophageal impedance using mucosal impedance catheter
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
Measured: During standard of care EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- 15 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 Vaezi, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318862
- Sponsor's protocol ID
- 130084
- Status last verified
- May 2026
- First submitted
- 4 Sep 2013
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
- ClinicalTrials.gov ID
- NCT02318862
- Acronym / sponsor ID
- 130084
- Keywords
- reflux, GERD, EGD, pH testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Dec 2014 (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 a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD | Other | Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testingThose who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing |
| non-GERD | Other | Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testingThose who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
- Previous diagnosis of reflux
- At least 18 years of age
Key exclusion criteria (4 listed)
- Those less than 18 years of age
- Unable to give informed consent
- Use of acid suppressive therapy within the last 10 days
- Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition
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 |
|---|---|---|
| Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing | Procedure or surgery | GERD, non-GERD |
Primary outcome
Measurement of lower esophageal impedance using mucosal impedance catheter
Time frame: During standard of care EGD
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
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 26 May 2026.
- 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 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?
A study of Gastroesophageal Reflux Disease (GERD) and Non-erosive Reflux Disease (NERD), 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 3 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 26 May 2026. 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?
Measurement of lower esophageal impedance using mucosal impedance catheter (time frame: During standard of care EGD). 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 26 May 2026.