Mucosal Impedance and Eosinophilic Esophagitis

NCT01953575 | Completed Results FDA Device

• 1 other identifier: 13-005778
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Eosinophilic Esophagitis

Keywords

Mucosal Impedance; Eosinophilic Esophagitis; EoE

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Active Eosinophilic Esophagitis

EXPERIMENTAL

Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy

Device: Mucosal Impedance; Procedure: Upper Endoscopy

Inactive Eosinophilic Esophagitis

EXPERIMENTAL

Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy

Device: Mucosal Impedance; Procedure: Upper Endoscopy

Control group

PLACEBO COMPARATOR

Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy

Procedure: Upper Endoscopy

Interventions

Mucosal Impedance DEVICE

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.

Also known as: ph impedance, ph monitor

Active Eosinophilic Esophagitis; Inactive Eosinophilic Esophagitis

Upper Endoscopy PROCEDURE

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.

Also known as: Esophagogastroduodenoscopy (EGD)

Active Eosinophilic Esophagitis; Control group; Inactive Eosinophilic Esophagitis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Gastroscopy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: David A. Katzka
• Organization: Mayo Clinic

Katzka.David@mayo.edu

507-284-4824

Study Officials

• David Katzka, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: September 1, 2013
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: April 15, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-04

Locations

US (1)