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

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03103789
• Other study ID #: 140470
• Status: Enrolling by invitation
• Start date: April 29, 2014
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Diagnostic Test:
• single catheter mucosal impedance testing

• balloon assembly mucosal impedance testing

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Endoscopy Laboratory	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Sandhill Scientific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mucosal impedance values	compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls	Values will be obtained at conclusion of EGD, an expected average of 6 minutes