Confocal Laser Microscopy in Non Erosive Reflux Disease

NCT00588939 | Completed DMC

• 1 other identifier: 07-006186
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acid Reflux Disease; Heartburn

Keywords

reflux; heartburn

Outcome Measures

Primary Outcomes (1)

• To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD

  at time of procedure

Secondary Outcomes (1)

• To assess the additional charges of implementing CLM in EGD

  at time of procedure

Study Arms (1)

I

participants with symptoms of acid reflux disease (heartburn)

Device: Cell~vizio (Laser connfocal microscopy)

Interventions

Cell~vizio (Laser connfocal microscopy) DEVICE

completed during endoscopy

Also known as: Mauna Kea Cellvizeo

I

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

age 18 - 65 years symptoms of acid reflux disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

esophageal biopsy

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth K Wang, MD

  Mayo Clinic

  STUDY DIRECTOR

• Rami Badreddine, MD

  Malyo Clinic Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VanCleve Professor of Gastroenterology Research

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 9, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

US (1)