Eosinophilic EsophagitisEoENCT01953575
Mucosal Impedance and Eosinophilic Esophagitis
A study testing Mucosal Impedance and Upper Endoscopy in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance? And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Mucosal Impedance and Upper Endoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 10 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
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 Gastroesophageal reflux disease (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: Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?
And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Mucosal Impedance, Upper Endoscopy
- Keywords
- Mucosal Impedance, Eosinophilic Esophagitis, EoE
- 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 ImpedanceDevice
Also called ph impedance, ph monitor
A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.
Upper EndoscopyProcedure or surgery
Also called Esophagogastroduodenoscopy (EGD)
Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.
| Study group | Role | What they receive |
|---|---|---|
| Active Eosinophilic Esophagitis | Experimental | Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy Receives: Device: Mucosal Impedance; Procedure: Upper Endoscopy |
| Inactive Eosinophilic Esophagitis | Experimental | Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy Receives: Device: Mucosal Impedance; Procedure: Upper Endoscopy |
| Control group | Placebo comparator | Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy Receives: Procedure: Upper Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Mucosal Impedance (MI)
An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.
Measured: baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David Katzka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953575
- Sponsor's protocol ID
- 13-005778
- Acronym
- EoE
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2013
- Last updated
- 15 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
- ClinicalTrials.gov ID
- NCT01953575
- Acronym / sponsor ID
- EoE / 13-005778
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Mucosal Impedance, Eosinophilic Esophagitis, EoE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?
And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Eosinophilic Esophagitis | Experimental | Device: Mucosal Impedance, Procedure: Upper EndoscopySubjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy |
| Inactive Eosinophilic Esophagitis | Experimental | Device: Mucosal Impedance, Procedure: Upper EndoscopySubjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy |
| Control group | Placebo comparator | Procedure: Upper EndoscopySubjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Gastroesophageal reflux disease (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 ImpedanceAlso: ph impedance, ph monitorA tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. | Device | Active Eosinophilic Esophagitis, Inactive Eosinophilic Esophagitis |
| Upper EndoscopyAlso: Esophagogastroduodenoscopy (EGD)Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. | Procedure or surgery | Active Eosinophilic Esophagitis, Control group, Inactive Eosinophilic Esophagitis |
Primary outcome
Esophageal Mucosal Impedance (MI)
Time frame: baseline to one year
An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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 Katzka, MD 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?
A study testing Mucosal Impedance and Upper Endoscopy in people with Eosinophilic Esophagitis, 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 15 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Esophageal Mucosal Impedance (MI) (time frame: baseline to one year). 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 15 Apr 2020.