Back to resultsHRIM vs Mucosal Impedance in GERD Participants
Primary Purpose
Gastro-esophageal Reflux Disease (GERD)
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mucosal Impedance
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro-esophageal Reflux Disease (GERD)
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mucosal Impedance
Arm Description
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.
Outcomes
Primary Outcome Measures
The mean impedance
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02812407
Brief Title
HRIM vs Mucosal Impedance in GERD Participants
Official Title
Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No linger a clinically relevant research question
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-esophageal Reflux Disease (GERD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mucosal Impedance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mucosal Impedance
Other Intervention Name(s)
Impedance
Intervention Description
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
Primary Outcome Measure Information:
Title
The mean impedance
Description
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value
Description
Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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HRIM vs Mucosal Impedance in GERD Participants
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