A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

Phase 4

Terminated

• Conditions: Barrett's Esophagus

• Registration Number: NCT01030263
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-11
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Whether specialized columnar epithelium was detected.	At biopsy on Day 0.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States