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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00588939
Other study ID # 07-006186
Secondary ID
Status Completed
Phase N/A
First received December 22, 2007
Last updated May 17, 2013
Start date November 2008
Est. completion date December 2012

Study information

Verified date May 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Cell~vizio (Laser connfocal microscopy)
completed during endoscopy

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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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