Mucosal Impedance and Eosinophilic Esophagitis (EoE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01953575|
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : October 11, 2017
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
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 firstname.lastname@example.org|
|Contact: Lori A. Kryzer 507-538-2403` email@example.com|
|Principal Investigator:||David Katzka, MD||Mayo Clinic|