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Mucosal Impedance and Eosinophilic Esophagitis (EoE)
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01953575
First received: September 26, 2013
Last updated: September 12, 2016
Last verified: September 2016
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Purpose
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 | Intervention |
|---|---|
| Eosinophilic Esophagitis | Device: Mucosal Impedance |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment |
Resource links provided by NLM:
Further study details as provided by David A. Katzka, Mayo Clinic:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953575
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953575
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | David Katzka, MD | Mayo Clinic |
More Information
| Responsible Party: | David A. Katzka, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01953575 History of Changes |
| Other Study ID Numbers: |
13-005778 |
| Study First Received: | September 26, 2013 |
| Last Updated: | September 12, 2016 |
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 |
ClinicalTrials.gov processed this record on June 26, 2017