Confocal Laser Microscopy in Non Erosive Reflux Disease - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588939

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)

MedlinePlus related topics: Endoscopy Heartburn

U.S. FDA Resources

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

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

Biospecimen Description:

esophageal biopsy

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Primary Completion Date:	February 2010 (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

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:

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

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:	Mayo Clinic ( Kenneth K Wang MD )
Study ID Numbers:	07-006186
Study First Received:	December 22, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00588939 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

reflux
heartburn

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Signs and Symptoms, Digestive
Heartburn
Gastroesophageal Reflux

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Heartburn

ClinicalTrials.gov processed this record on May 07, 2009