Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 6/21/2018 |
| Start Date: | April 29, 2014 |
| End Date: | August 31, 2019 |
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.
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.
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.
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.
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
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