Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease
Completed
Conditions studied: GERD
In brief
When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD). Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming. The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD. Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.
Key facts
- Study ID
- NCT02629081
- Run by
- Loren Laine
- People needed
- 90
- Starts
- 2015-03-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-07-12
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs
You may not qualify if…
- Patients who have evidence of erosive esophagitis under white-light endoscopy
- Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
- Patients unable or unwilling to sign informed consent
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- VACHS — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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