Eosinophilic EsophagitisNCT02995395
Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)
An observational study of Eosinophilic Esophagitis and Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis, Healthy
- What is being tested?
- Mucosal Impedance Balloon catheter
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Aug 2020
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper endoscopy for dysphagia or GERD
Who may be able to join
- Adults ages 18-90 undergoing clinically indicated upper endoscopy
- Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
- Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.
Who cannot join
- Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis
This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.
Read the detailed description
The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies. Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies.
For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.
- Conditions
- Eosinophilic Esophagitis, Healthy
- Being tested
- Mucosal Impedance Balloon catheter
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosal Impedance Balloon catheterDevice
Also called Impedance balloon testing
During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.
- The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Mucosal Impedance Balloon catheter | At the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously. Receives: Device: Mucosal Impedance Balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diminished mucosal impedance in patients with Eosinophilic Esophagitis
Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 Oct 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2020
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 Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sandhill Scientific
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David A Katzka, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995395
- Sponsor's protocol ID
- 16-005863
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexander JA, Ravi K, Geno DM, Tholen CJ, Higginbotham TC, Wildhorn S, Camilleri M, Vaezi MF, Katzka DA. Comparison of mucosal impedance measurements throughout the esophagus and mucosal eosinophil counts in endoscopic biopsy specimens in eosinophilic esophagitis. Gastrointest Endosc. 2019 Apr;89(4):693-700.e1. doi: 10.1016/j.gie.2018.08.031. Epub 2018 Aug 24.
PubMed 30145316
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02995395
- Acronym / sponsor ID
- 16-005863
- Conditions
- Eosinophilic Esophagitis, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Sandhill Scientific
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Dec 2016 (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.
This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.
Detailed description
The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies. Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies.
For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucosal Impedance Balloon catheter | – | Device: Mucosal Impedance Balloon catheterAt the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper endoscopy for dysphagia or GERD
Key inclusion criteria (3 listed)
- Adults ages 18-90 undergoing clinically indicated upper endoscopy
- Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
- Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.
Key exclusion criteria (3 listed)
- Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
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 |
|---|---|---|
| Mucosal Impedance Balloon catheterAlso: Impedance balloon testingDuring the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope. o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded. | Device | Mucosal Impedance Balloon catheter |
Primary outcome
Diminished mucosal impedance in patients with Eosinophilic Esophagitis
Time frame: 1 year
Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.
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 Feb 2021.
- Derived from this study: PubMed 30145316Alexander JA, Ravi K, Geno DM, Tholen CJ, Higginbotham TC, Wildhorn S, Camilleri M, Vaezi MF, Katzka DA. Comparison of mucosal impedance measurements throughout the esophagus and mucosal eosinophil counts in endoscopic biopsy specimens in eosinophilic esophagitis. Gastrointest Endosc. 2019 Apr;89(4):693-700.e1. doi: 10.1016/j.gie.2018.08.031. Epub 2018 Aug 24.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
David A Katzka principal investigator
Mayo Clinic
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 Eosinophilic Esophagitis and Healthy, run by Mayo Clinic 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 3 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 Feb 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?
Diminished mucosal impedance in patients with Eosinophilic Esophagitis (time frame: 1 year). 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 NCT02995395, 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 Feb 2021.