Confocal Laser Microscopy in Non Erosive Reflux Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00588939

Enrollment

Registered

2008-01-09

Start date

2008-11-30

Completion date

2012-12-31

Last updated

2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid Reflux Disease, Heartburn

Keywords

reflux, heartburn

Brief 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.

Detailed 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

Interventions

DEVICECell~vizio (Laser connfocal microscopy)

completed during endoscopy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD	at time of procedure

Secondary

Measure	Time frame
To assess the additional charges of implementing CLM in EGD	at time of procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026