Gastroesophageal Reflux Disease (GERD)NCT02320981
Mucosal Impedance in Pediatric Population
An observational study of Gastroesophageal Reflux Disease (GERD) and Eosinophilic Esophagitis (EoE), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Eosinophilic Esophagitis (EoE), Functional Dyspepsia
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2016
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients of our Vanderbilt Pediatric Gastroenterology Clinic undergoing routine evaluation of dyspepsia with endoscopy that meet the inclusion/exclusion criteria as defined above.
Who may be able to join
- Patients between 1 year and 18 years of age
- Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia
Who cannot join
- Families unable to give informed consent/assent;
- Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
About this study
Official title: Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.
Read the detailed description
The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.
- Conditions
- Gastroesophageal Reflux Disease (GERD), Eosinophilic Esophagitis (EoE), Functional Dyspepsia
- Being tested
- Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance
- Keywords
- GERD, EGD, pH testing, eosinophilic esophagitis, impedance testing
- Medical subject headings
- Gastroesophageal Reflux, Eosinophilic Esophagitis
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 measurement of mucosal impedanceDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| EGD with Biopsy | Pediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance Receives: Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)
Mucosal impedance will be obtained during standard of care endoscopy and results will be available immediately. For those patients who may be undergoing ph monitoring as standard of care, those data will be compared to the mucosal impedance values obtained at bedside.
Measured: 5 minutes
Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE
Measured: 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 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionSep 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 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
- Mary Allyson Lowry, MD, Principal investigator, Vanderbilt University Medical CenterSari Acra, MD, Principal investigator, Vanderbilt University Medical CenterMichael Vaezi, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320981
- Sponsor's protocol ID
- IRB 140987
- Other IDs
- T32DK007673-21
- Status last verified
- Apr 2017
- First submitted
- 14 Jul 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02320981
- Acronym / sponsor ID
- IRB 140987
- Conditions
- Gastroesophageal Reflux Disease (GERD), Eosinophilic Esophagitis (EoE), Functional Dyspepsia
- Keywords
- GERD, EGD, pH testing, eosinophilic esophagitis, impedance testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 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.
Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.
Detailed description
The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGD with Biopsy | – | Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedancePediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients of our Vanderbilt Pediatric Gastroenterology Clinic undergoing routine evaluation of dyspepsia with endoscopy that meet the inclusion/exclusion criteria as defined above.
Key inclusion criteria (2 listed)
- Patients between 1 year and 18 years of age
- Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia
Key exclusion criteria (2 listed)
- Families unable to give informed consent/assent;
- Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions
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 measurement of mucosal impedance | Diagnostic test | EGD with Biopsy |
Primary outcome
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)
Time frame: 5 minutes
Mucosal impedance will be obtained during standard of care endoscopy and results will be available immediately. For those patients who may be undergoing ph monitoring as standard of care, those data will be compared to the mucosal impedance values obtained at bedside.
Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE
Time frame: 5 minutes
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 1 May 2017.
- 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.
Mary Allyson Lowry, MD principal investigator
Vanderbilt University Medical Center
Sari Acra, MD principal investigator
Vanderbilt University Medical Center
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 (GERD) and Eosinophilic Esophagitis (EoE), 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 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 1 May 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?
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?
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE) (time frame: 5 minutes). 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 1 May 2017.