Overview

This trial is active, not recruiting.

Condition eosinophilic esophagitis
Treatment mucosal impedance
Sponsor Mayo Clinic
Start date September 2013
End date July 2017
Trial size 60 participants
Trial identifier NCT01953575, 13-005778

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
mucosal impedance ph 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).

Primary Outcomes

Measure
Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy.
time frame: basesline to one year

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Principal investigator David Katzka, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.