GERDNCT01556919
Esophageal Monitoring Device for Assessing Mucosal Impedance
An observational study of GERD and Esophagitis, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Esophagitis
- Type of treatment
- Surgery or procedure
- How many people
- 429 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 23 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for an esophagogastroduodenoscoy (EGD) for one of the following reasons: diagnosed with Gastroesophegeal reflux disease (GERD); have a normal esophageal mucosa but an abnormal pH testing (acid measurement); or a normal esophagus and normal pH testing
Who may be able to join
- Patients who are undergoing standard of care EGD with or without BRAVO placement;
- Have GERD symptoms and/or have endoscopic esophagitis
Who cannot join
- Use of acid suppressive therapy within last 10 days;
- Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232
About this study
Official title: Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.
Read the detailed description
During routine esophagogastroduodenoscopy (EGD), consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. Each catheter will be manually guided by the physician through the working channel of the endoscope until the sensored tip is visible through the scope camera. The physician will place the sensored rings directly on the mucosa along the lumen. To obtain evaluable data, the sensors must remain in contact with the mucosa at each point for 5 seconds after a stable impedance reading has been captured. This process will be repeated for each of the three prototype catheters in each consented patient in order to determine the optimal catheter/sensor design. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
- Conditions
- GERD, Esophagitis
- Being tested
- Standard of care endoscopy
- Keywords
- GERD, Esophagitis
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care endoscopyProcedure or surgery
standard of care endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Mucosal Impedance Probe | Not described Receives: Procedure: Standard of care endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Impedance Values
Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
Measured: Values will be obtained at conclusion of EGD, an expected average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
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 GERDStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556919
- Sponsor's protocol ID
- 120126
- Status last verified
- Jul 2021
- First submitted
- 12 Mar 2012
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Ates F, Yuksel ES, Higginbotham T, Slaughter JC, Mabary J, Kavitt RT, Garrett CG, Francis D, Vaezi MF. Mucosal impedance discriminates GERD from non-GERD conditions. Gastroenterology. 2015 Feb;148(2):334-43. doi: 10.1053/j.gastro.2014.10.010. Epub 2014 Oct 16.
PubMed 25448923
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
- ClinicalTrials.gov ID
- NCT01556919
- Acronym / sponsor ID
- 120126
- Conditions
- GERD, Esophagitis
- Keywords
- GERD, Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 19 Mar 2012 (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.
The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.
Detailed description
During routine esophagogastroduodenoscopy (EGD), consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. Each catheter will be manually guided by the physician through the working channel of the endoscope until the sensored tip is visible through the scope camera. The physician will place the sensored rings directly on the mucosa along the lumen. To obtain evaluable data, the sensors must remain in contact with the mucosa at each point for 5 seconds after a stable impedance reading has been captured. This process will be repeated for each of the three prototype catheters in each consented patient in order to determine the optimal catheter/sensor design. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucosal Impedance Probe | – | Procedure: Standard of care endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for an esophagogastroduodenoscoy (EGD) for one of the following reasons: diagnosed with Gastroesophegeal reflux disease (GERD); have a normal esophageal mucosa but an abnormal pH testing (acid measurement); or a normal esophagus and normal pH testing
Key inclusion criteria (2 listed)
- Patients who are undergoing standard of care EGD with or without BRAVO placement;
- Have GERD symptoms and/or have endoscopic esophagitis
Key exclusion criteria (2 listed)
- Use of acid suppressive therapy within last 10 days;
- Known history of Barrett's esophagus, gastric surgery, alcoholism, 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 endoscopystandard of care endoscopy | Procedure or surgery | Mucosal Impedance Probe |
Primary outcome
Mucosal Impedance Values
Time frame: Values will be obtained at conclusion of EGD, an expected average of 5 minutes
Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.
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 3 Aug 2021.
- Derived from this study: PubMed 25448923Ates F, Yuksel ES, Higginbotham T, Slaughter JC, Mabary J, Kavitt RT, Garrett CG, Francis D, Vaezi MF. Mucosal impedance discriminates GERD from non-GERD conditions. Gastroenterology. 2015 Feb;148(2):334-43. doi: 10.1053/j.gastro.2014.10.010. Epub 2014 Oct 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GERD and Esophagitis, 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 2 inclusion and 2 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 3 Aug 2021. 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?
Mucosal Impedance Values (time frame: Values will be obtained at conclusion of EGD, an expected average of 5 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 NCT01556919, 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 3 Aug 2021.