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OpenTrials
Completed

NCT Number: NCT00588939

Confocal Laser Microscopy in Non Erosive Reflux Disease

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
  • Patients who are able to give informed consent

Exclusion criteria

  • Patients with a history of Erosive esophagitis
  • Patients with a history of Barrett's esophagus
  • Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
  • Patients who are unable or unwilling to undergo endoscopic evaluation
  • Patients who are unable to give informed consent
  • Patients with a known coagulopathy who are unable to be off therapy

Treatment and study plan

Cell~vizio (Laser connfocal microscopy)

Device

completed during endoscopy

Other names: Mauna Kea Cellvizeo

Primary outcomes

  1. To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD

    Time frame: at time of procedure

Secondary outcomes

  1. To assess the additional charges of implementing CLM in EGD

    Time frame: at time of procedure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2008
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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