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A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

This study has been terminated.
(The investigators left the institution.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01030263
First received: December 7, 2009
Last updated: March 24, 2010
Last verified: March 2010
History of Changes
  Purpose

We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.


Condition Intervention Phase
Barrett's Esophagus
 Other: Fluorescence-aided confocal endomicroscopy guided biopsy.
Other: Random four-quadrant biopsies.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Whether specialized columnar epithelium was detected. [ Time Frame: At biopsy on Day 0. ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEM
Biopsies obtained with fluorescence-aided confocal endomicroscopy.
 Other: Fluorescence-aided confocal endomicroscopy guided biopsy.
Fluorescence-aided confocal endomicroscopy guided biopsy.
RFQ
Random four-quadrant biopsies.
 Other: Random four-quadrant biopsies.
Random four-quadrant biopsies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18.
  • Barrett's esophagus
  • Acid suppressive therapy
  • Endoscopic surveillance

Exclusion Criteria:

  • Pregnancy or lactation
  • Allergy to fluorescein
  • Endoscopic esophagitis Los Angeles classification A to D
  • Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
  • Obvious mass lesions or cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030263

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ananya Das, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Ananya Das MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01030263     History of Changes
Other Study ID Numbers: 08-001090
Study First Received: December 7, 2009
Last Updated: March 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013