Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)



Status:Recruiting
Conditions:Healthy Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 90
Updated:2/21/2019
Start Date:October 1, 2017
End Date:August 1, 2020

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The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis

This study will evaluate the role the balloon mucosal impedance may have in diagnosing and
monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the
balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.

The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies.
Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect
of treatment" using a new technology allowing for direct assessment of mucosal impedance at
the time of routine upper endoscopy to assess esophageal integrity and disease activity and
alevate the need for biopsies.

For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly
to provide precise measurements over a broad area of esophageal epithelium, while eliminating
the fluids and spanning across a 10 mm luminal area using the same direct assessment as the
mucosal impedance at the time of routine upper endoscopy.

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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-0367
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