Confocal Laser Microscopy in Non Erosive Reflux Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acid Reflux Disease Heartburn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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I

participants with symptoms of acid reflux disease (heartburn)

Cell~vizio (Laser connfocal microscopy)

Intervention Type DEVICE

completed during endoscopy

Interventions

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Cell~vizio (Laser connfocal microscopy)

completed during endoscopy

Intervention Type DEVICE

Other Intervention Names

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Mauna Kea Cellvizeo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No