[Impedance Measurement for Non-Erosive Reflux Disease

NCT02997527 | Withdrawn

• 1 other identifier: 16-007762
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine if people with and without GERD or trouble swallowing have increased esophageal mucosa impedance (food getting into the esophageal tissue).

Conditions

GERD; Healthy

Outcome Measures

Primary Outcomes (1)

• Epithelial integrity in GERD an Non-GERD subjects

  A special sensor array (Mucosal Impedance) composed of 360\_ circumferential sensing rings was engineered and mounted on a 2-mm-diameter soft catheter easily traversable through the working channel of an upper endoscope. The frequency for the measuring circuit was set at 2 kHz. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to the current, according to Ohm's law (voltage ¼ IR). Data will be acquired with a stationary impedance data acquisition system and viewed and analyzed on BioView Analysis software. Impedance measurements will be obtained at 1,2,3,4, 5 cm at the 6 O'clock position above the gastroesophageal junction

  1 year

Secondary Outcomes (1)

• Epithelial integrity by Mucosal Impedance verses gold standard Ambulatory pH monitoring

  1 year

Study Arms (1)

Intraluminal impedance testing

EXPERIMENTAL

During the participant's clinical endoscopy the 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. * The catheter (tiny tube) will be placed through the endoscope in your esophagus 1 cm above where your stomach and esophagus meet for 5 seconds. * At 2 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds * And at 3 cm above where the participants stomach and esophagus meet the catheter will be placed for 5 seconds. * At 4 cm above where the participants stomach and esophagus meet the catheter will be placed for 5 seconds. * At 5 cm above where the participants stomach and esophagus meet the catheter will be placed for 5 seconds.

Device: Intraluminal Impedance

Interventions

Intraluminal Impedance DEVICE

Esophageal impedance testing measures epithelial integrity as reflected through the ability of the mucosa to conduct electric current. Recently, a site specific endoscopically placed impedance probe has been developed that can measure esophageal mucosal impedance at any point of the esophagus.

Also known as: Impedance testing

Intraluminal impedance testing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-90
• Patients with heartburn and no hiatal hernia undergoing clinically indicated endoscopy
• Patients with heartburn and a hiatal hernia \> 3cm undergoing clinically indicated endoscopy
• Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD
• Patients with reflux symptoms, a normal appearing esophagus on clinically indicated endoscopy undergoing clinically indicated ambulatory pH/impedance testing.

You may not qualify if:

• Previous gastric or esophageal surgery.
• Use of proton pump inhibitors 1 month prior to the study
• Patients on anticoagulation other than aspirin or clopidogrel
• Presence of erosive esophagitis or Barrett's esophagus

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Acoustic Impedance Tests

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David A Katzka

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David A. Kazka, MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)