Clinical trial NCT02995395: Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)
Official title: The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Sandhill Scientific
First posted: 2016-12-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper endoscopy for dysphagia or GERD

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diminished mucosal impedance in patients with Eosinophilic Esophagitis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David A Katzka
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander JA, Ravi K, Geno DM, Tholen CJ, Higginbotham TC, Wildhorn S, Camilleri M, Vaezi MF, Katzka DA. Comparison of mucosal impedance measurements throughout the esophagus and mucosal eosinophil counts in endoscopic biopsy specimens in eosinophilic esophagitis. Gastrointest Endosc. 2019 Apr;89(4):693-700.e1. doi: 10.1016/j.gie.2018.08.031. Epub 2018 Aug 24.