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Clinical Trials/NCT01030263
NCT01030263
Terminated
Phase 4

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

Mayo Clinic1 site in 1 country18 target enrollmentJune 2008
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ConditionsBarrett's Esophagus

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Barrett's Esophagus
Sponsor
Mayo Clinic
Enrollment
18
Locations
1
Primary Endpoint
Whether specialized columnar epithelium was detected.
Status
Terminated
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
March 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age at least
  • •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

Outcomes

Primary Outcomes

Whether specialized columnar epithelium was detected.

Time Frame: At biopsy on Day 0.

Study Sites (1)

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