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Confocal Laser Microscopy in Non Erosive Reflux Disease

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00588939
Collaborator
(none)
60
Enrollment
1
Location
49
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Nov 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
I

participants with symptoms of acid reflux disease (heartburn)

Device: Cell~vizio (Laser connfocal microscopy)
completed during endoscopy
Other Names:
  • Mauna Kea Cellvizeo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD [at time of procedure]

    Secondary Outcome Measures

    1. To assess the additional charges of implementing CLM in EGD [at time of procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55901

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Study Director: Kenneth K Wang, MD, Mayo Clinic
    • Principal Investigator: Rami Badreddine, MD, Malyo Clinic Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kenneth K. Wang, VanCleve Professor of Gastroenterology Research, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00588939
    Other Study ID Numbers:
    • 07-006186
    First Posted:
    Jan 9, 2008
    Last Update Posted:
    May 21, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Kenneth K. Wang, VanCleve Professor of Gastroenterology Research, Mayo Clinic
    reflux
    heartburn
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Heartburn

    Study Results

    No Results Posted as of May 21, 2013