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HRIM vs Mucosal Impedance in GERD Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812407
Recruitment Status : Withdrawn (No linger a clinically relevant research question)
First Posted : June 24, 2016
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date June 9, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
The mean impedance [ Time Frame: 2 years ]
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HRIM vs Mucosal Impedance in GERD Participants
Official Title  ICMJE Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastro-esophageal Reflux Disease (GERD)
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Device: Mucosal Impedance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 4, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2016)
40
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812407
Other Study ID Numbers  ICMJE 16-003580
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karthik Ravi, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karthik Ravi, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP