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HRIM vs Mucosal Impedance in GERD Participants

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ClinicalTrials.gov Identifier: NCT02812407
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., 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?

Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Disease (GERD) Device: Mucosal Impedance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: 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.

Device: 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
Other Name: Impedance




Primary Outcome Measures :
  1. The mean impedance [ Time Frame: 2 years ]
    The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD


Secondary Outcome Measures :
  1. Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812407


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Karthik Ravi, MD Mayo Clinic

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Responsible Party: Karthik Ravi, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02812407     History of Changes
Other Study ID Numbers: 16-003580
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases