Expired Study
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Rochester, Minnesota 55901


Purpose:

Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.


Study summary:

Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM


Criteria:

Inclusion Criteria: 1. Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease 2. Patients who are able to give informed consent Exclusion Criteria: 1. Patients with a history of Erosive esophagitis 2. Patients with a history of Barrett's esophagus 3. Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices 4. Patients who are unable or unwilling to undergo endoscopic evaluation 5. Patients who are unable to give informed consent 6. Patients with a known coagulopathy who are unable to be off therapy


NCT ID:

NCT00588939


Primary Contact:

Study Director
Kenneth K Wang, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55901
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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