Heartburn Clinical Trial
Official title:
Confocal Laser Microscopy in Non Erosive Reflux Disease
Verified date | May 2013 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD | at time of procedure | No | |
Secondary | To assess the additional charges of implementing CLM in EGD | at time of procedure | No |
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