Mucosal Impedance and Eosinophilic Esophagitis (EoE)
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ClinicalTrials.gov Identifier: NCT01953575 |
Recruitment Status
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Recruiting
First Posted
: October 1, 2013
Last Update Posted
: October 11, 2017
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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?
Condition or disease | Intervention/treatment | Phase |
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Eosinophilic Esophagitis | Device: Mucosal Impedance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment |
Study Start Date : | September 2013 |
Estimated Primary Completion Date : | August 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Mucosal Impedance
Patients with Eosinophilic Esophagitis and patient without trouble swallowing,during your clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it.
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Device: Mucosal Impedance
Mucosal impedance- a (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds.
This will determine if people with eosinophilic esophagitis (EoE) have an increased esophageal mucosa impedance (food getting into the esophageal tissue). Other Names:
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- Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. [ Time Frame: basesline to one year ]As a pilot, ten patients will be studied before and after treatment for eosinophilic esophagitis. This number of patients will be increased if there are treatment failures until there is a total of ten effectively treated patients studied. Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. Ten control patients without esophageal disease will be studied.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953575
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Debra M. Geno, CCRP 507-538-0367 geno.debra@mayo.edu | |
Contact: Lori A. Kryzer 507-538-2403` kryzer.lori@mayo.edu |
Principal Investigator: | David Katzka, MD | Mayo Clinic |
Responsible Party: | David A. Katzka, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01953575 History of Changes |
Other Study ID Numbers: |
13-005778 |
First Posted: | October 1, 2013 Key Record Dates |
Last Update Posted: | October 11, 2017 |
Last Verified: | October 2017 |
Keywords provided by David A. Katzka, Mayo Clinic:
Mucosal Impedance Eosinophilic Esophagitis EoE |
Additional relevant MeSH terms:
Eosinophilic Esophagitis Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |