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Mucosal Impedance and Eosinophilic Esophagitis (EoE)

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mucosal Impedance
Upper Endoscopy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis focused on measuring Mucosal Impedance, Eosinophilic Esophagitis, EoE

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Active Eosinophilic Esophagitis

Inactive Eosinophilic Esophagitis

Control group

Arm Description

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

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

Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2013
Last Updated
April 1, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01953575
Brief Title
Mucosal Impedance and Eosinophilic Esophagitis
Acronym
EoE
Official Title
Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Mucosal Impedance, Eosinophilic Esophagitis, EoE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Eosinophilic Esophagitis
Arm Type
Experimental
Arm Description
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
Arm Title
Inactive Eosinophilic Esophagitis
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy
Intervention Type
Device
Intervention Name(s)
Mucosal Impedance
Other Intervention Name(s)
ph impedance, ph monitor
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Upper Endoscopy
Other Intervention Name(s)
Esophagogastroduodenoscopy (EGD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Esophageal Mucosal Impedance (MI)
Description
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.
Time Frame
baseline to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Katzka, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Mucosal Impedance and Eosinophilic Esophagitis

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