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Confocal Laser Microscopy in Non Erosive Reflux Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588939
First received: December 22, 2007
Last updated: May 17, 2013
Last verified: May 2013

December 22, 2007
May 17, 2013
November 2008
December 2012   (final data collection date for primary outcome measure)
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588939 on ClinicalTrials.gov Archive Site
To assess the additional charges of implementing CLM in EGD [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Confocal Laser Microscopy in Non Erosive Reflux Disease
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

esophageal biopsy

Non-Probability Sample

age 18 - 65 years symptoms of acid reflux disease

  • Acid Reflux Disease
  • Heartburn
Device: Cell~vizio (Laser connfocal microscopy)
completed during endoscopy
Other Name: Mauna Kea Cellvizeo
I
participants with symptoms of acid reflux disease (heartburn)
Intervention: Device: Cell~vizio (Laser connfocal microscopy)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588939
07-006186
Yes
Kenneth K. Wang, Mayo Clinic
Mayo Clinic
Not Provided
Study Director: Kenneth K Wang, MD Mayo Clinic
Principal Investigator: Rami Badreddine, MD Malyo Clinic Rochester
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP