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Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

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: NCT03103789
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2017
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Sandhill Scientific
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center

Brief Summary:
The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

Condition or disease Intervention/treatment
Gastro Esophageal Reflux Diagnostic Test: single catheter mucosal impedance testing Diagnostic Test: balloon assembly mucosal impedance testing

Detailed Description:

During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.

Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Actual Study Start Date : April 29, 2014
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
GERD patients
Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly.
Diagnostic Test: single catheter mucosal impedance testing
Diagnostic Test: balloon assembly mucosal impedance testing
control
Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly.
Diagnostic Test: single catheter mucosal impedance testing
Diagnostic Test: balloon assembly mucosal impedance testing



Primary Outcome Measures :
  1. mucosal impedance values [ Time Frame: Values will be obtained at conclusion of EGD, an expected average of 6 minutes ]
    compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who are scheduled for endoscopic procedures (esophagogastroduodenoscopy (EGD)) by the principal investigator as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study.
Criteria

Inclusion Criteria:

  • Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement

Exclusion Criteria:

  • Age less than 18 years old
  • Patients unable to give informed consent
  • Use of acid suppressive therapy within last 10 days
  • Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication

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): NCT03103789


Locations
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United States, Tennessee
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Sandhill Scientific
Investigators
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Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03103789    
Other Study ID Numbers: 140470
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases