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Confocal Laser Microscopy in Non Erosive Reflux Disease

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ClinicalTrials.gov Identifier: NCT00588939
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : May 21, 2013
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

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.

Condition or disease Intervention/treatment
Acid Reflux Disease Heartburn Device: Cell~vizio (Laser connfocal microscopy)

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

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Laser Microscopy in Non Erosive Reflux Disease
Study Start Date : November 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

Group/Cohort Intervention/treatment
participants with symptoms of acid reflux disease (heartburn)
Device: Cell~vizio (Laser connfocal microscopy)
completed during endoscopy
Other Name: Mauna Kea Cellvizeo

Primary Outcome Measures :
  1. To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD [ Time Frame: at time of procedure ]

Secondary Outcome Measures :
  1. To assess the additional charges of implementing CLM in EGD [ Time Frame: at time of procedure ]

Biospecimen Retention:   Samples Without DNA
esophageal biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
age 18 - 65 years symptoms of acid reflux disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588939

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Study Director: Kenneth K Wang, MD Mayo Clinic
Principal Investigator: Rami Badreddine, MD Malyo Clinic Rochester

Additional Information:
Responsible Party: Kenneth K. Wang, VanCleve Professor of Gastroenterology Research, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588939     History of Changes
Other Study ID Numbers: 07-006186
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Kenneth K. Wang, Mayo Clinic:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms