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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Mayo Clinic
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Updated on 5 January 2021
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eosinophil count
dysphagia
endoscopy
proton pump inhibitors
gastroesophageal reflux
esophagitis
upper endoscopy
esophageal biopsy
acid reflux / gastroesophageal reflux

Summary

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.

Description

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.

Details
Condition Eosinophilic esophagitis, Healthy
Age 18years - 90years
Treatment Mucosal Impedance Balloon catheter
Clinical Study IdentifierNCT02995395
SponsorMayo Clinic
Last Modified on5 January 2021

Eligibility

 Yes No Not Sure

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
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eosinophil count
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