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Mucosal Impedance and Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT01953575
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Study Description
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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?


Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: Mucosal Impedance Not Applicable

Study Design
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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 : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

  • The catheter (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.
  • At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds
  • And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds.
 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.

  • At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds
  • And at 20 cm above where your stomach and esophagus meet the catheter will be placed 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:
  • ph impedance
  • ph monitor


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David Katzka, MD Mayo Clinic
More Information
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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: November 9, 2018
Last Verified: November 2018

Keywords provided by David A. Katzka, Mayo Clinic:
Mucosal Impedance
Eosinophilic Esophagitis
EoE

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases