HRIM vs Mucosal Impedance in GERD Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-08-31

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?

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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.

Conditions

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Gastro-esophageal Reflux Disease (GERD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mucosal Impedance

Intervention Type DEVICE

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

Interventions

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Mucosal Impedance

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

Intervention Type DEVICE

Other Intervention Names

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Impedance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No