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OpenTrials
Completed

NCT Number: NCT02995395

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mucosal Impedance Balloon catheter

Device

During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.

o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.

Other names: Impedance balloon testing

Primary outcomes

  1. Diminished mucosal impedance in patients with Eosinophilic Esophagitis

    Time frame: 1 year

    Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Sandhill Scientific

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 16, 2016
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.