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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995395
• Other study ID #: 16-005863
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Healthy

Intervention

Device:
• Mucosal Impedance Balloon catheter
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sandhill Scientific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diminished mucosal impedance in patients with Eosinophilic Esophagitis	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.	1 year

External Links

•   Mayo Clinic Clinical Trials