HRIM vs Mucosal Impedance in GERD Participants

Not Applicable

Withdrawn

• Conditions: Gastro-esophageal Reflux Disease (GERD)
• Interventions: Device: Mucosal Impedance

• Registration Number: NCT02812407
• Lead Sponsor: Mayo Clinic

Brief Summary

Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?

Detailed Description

Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-09
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mucosal Impedance	Mucosal Impedance	Patient's having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study. During the clinical endoscopy, the 2.13 mm catheter will be passed through the channel of the standard endoscope this is called an Intraluminal Impedance. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it.

Primary Outcome Measures

Name	Time	Method
The mean impedance	2 years	The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD

Secondary Outcome Measures

Name	Time	Method
Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value	2 years	Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States