Gastro Esophageal RefluxNCT03103789
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
An observational study of Gastro Esophageal Reflux, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- single catheter mucosal impedance testing and balloon assembly mucosal impedance testing
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2014to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Adult, Older adult
Study population: Patients who are scheduled for endoscopic procedures (esophagogastroduodenoscopy (EGD)) by the principal investigator as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study.
Who may be able to join
- Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement
Who cannot join
- Age less than 18 years old
- Patients unable to give informed consent
- Use of acid suppressive therapy within last 10 days
- Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232
About this study
The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.
Read the detailed description
During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.
Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- single catheter mucosal impedance testing, balloon assembly mucosal impedance testing
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single catheter mucosal impedance testingDiagnostic test
balloon assembly mucosal impedance testingDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| GERD patients | Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly. Receives: Diagnostic Test: single catheter mucosal impedance testing; Diagnostic Test: balloon assembly mucosal impedance testing | |
| control | Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly. Receives: Diagnostic Test: single catheter mucosal impedance testing; Diagnostic Test: balloon assembly mucosal impedance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucosal impedance values
compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls
Measured: Values will be obtained at conclusion of EGD, an expected average of 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start29 Apr 2014
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sandhill Scientific
- 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
- NCT03103789
- Sponsor's protocol ID
- 140470
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2017
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.
PubMed 30711626
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
- ClinicalTrials.gov ID
- NCT03103789
- Acronym / sponsor ID
- 140470
- Conditions
- Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Sandhill Scientific
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Apr 2017 (actual)
- 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.
The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.
Detailed description
During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.
Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD patients | – | Diagnostic Test: single catheter mucosal impedance testing, Diagnostic Test: balloon assembly mucosal impedance testingPatients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly. |
| control | – | Diagnostic Test: single catheter mucosal impedance testing, Diagnostic Test: balloon assembly mucosal impedance testingPatients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for endoscopic procedures (esophagogastroduodenoscopy (EGD)) by the principal investigator as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study.
Key inclusion criteria (1 listed)
- Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement
Key exclusion criteria (4 listed)
- Age less than 18 years old
- Patients unable to give informed consent
- Use of acid suppressive therapy within last 10 days
- Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication
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 |
|---|---|---|
| single catheter mucosal impedance testing | Diagnostic test | GERD patients, control |
| balloon assembly mucosal impedance testing | Diagnostic test | GERD patients, control |
Primary outcome
mucosal impedance values
Time frame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes
compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 30711626Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.
- 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.
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 Gastro Esophageal Reflux, 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 1 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
mucosal impedance values (time frame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103789, which also lists 1 linked publication.
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 5 Oct 2026.