- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953575
Mucosal Impedance and Eosinophilic Esophagitis (EoE)
April 1, 2020 updated by: David A. Katzka, Mayo Clinic
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Eosinophilic Esophagitis
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
|
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.
Other Names:
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.
Other Names:
|
Experimental: Inactive Eosinophilic Esophagitis
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
|
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.
Other Names:
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.
Other Names:
|
Placebo Comparator: Control group
Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Katzka, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
June 10, 2019
Study Completion (Actual)
June 10, 2019
Study Registration Dates
First Submitted
September 26, 2013
First Submitted That Met QC Criteria
September 26, 2013
First Posted (Estimate)
October 1, 2013
Study Record Updates
Last Update Posted (Actual)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-005778
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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