Mucosal Impedance and Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953575
• Other study ID #: 13-005778
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: June 10, 2019

Study information

• Verified date: April 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?

And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• 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 Gastroesophageal reflux disease (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

Intervention

Device:
• Mucosal Impedance
A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.

Procedure:
• Upper Endoscopy
Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal Mucosal Impedance (MI)	An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.	baseline to one year

External Links

•   Mayo Clinic Clinical Trials