HRIM vs Mucosal Impedance in GERD Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients

Conditions
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Gastro-esophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: Mucosal Impedance


Participation Criteria
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Eligibility Criteria
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Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study. Inclusion criteria: Adults ages 18-90 Patients scheduled for or have completed a HRIM ( within 5 days) Patients scheduled for or recently have completed a MII-pH studies ( within 5 days) Patients scheduled for EGD Exclusion criteria: Technically limited esophageal HRIM or MII-pH study Patients with HRIM and MII-pH studies not performed within 5 days of each other Patients with EGD not performed within 30 days of HRIM and MII-pH studies Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucosal Impedance<br>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. | Device: Mucosal Impedance<br>* 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. The Intraluminal impedance (made by Sandhill Scientific) has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it. The catheter gives the investigators a reading at each level. The catheter will be placed on the esophageal mucosa 5 cm above the gastroesophageal junction (where the stomach and esophagus meet) for 5 second At 10 cm above the gastroesophageal junction the catheter will be placed for 5 seconds And at 20 cm<br>* Other names: Impedance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean impedance | The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD | 2 years | 

Secondary Outcome Measures

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