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Confocal Laser Microscopy in Non Erosive Reflux Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588939
First received: December 22, 2007
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Acid Reflux Disease
Heartburn
 Device: Cell~vizio (Laser connfocal microscopy)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Laser Microscopy in Non Erosive Reflux Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess the additional charges of implementing CLM in EGD [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

esophageal biopsy


Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
participants with symptoms of acid reflux disease (heartburn)
 Device: Cell~vizio (Laser connfocal microscopy)
completed during endoscopy
Other Name: Mauna Kea Cellvizeo

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

age 18 - 65 years symptoms of acid reflux disease

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588939

Locations
United States, Minnesota
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
  More Information

Additional Information:
Barrett's Esophagus Research Unit  This link exits the ClinicalTrials.gov site
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: December 22, 2007
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
reflux
heartburn

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

ClinicalTrials.gov processed this record on May 16, 2013