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NCT01030263 Clinical Trial

A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01030263
Other study ID # 08-001090
Secondary ID
Status Terminated
Phase Phase 4
First received December 7, 2009
Last updated March 24, 2010
Start date June 2008
Est. completion date March 2010

Study information
Verified date March 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• Fluorescence-aided confocal endomicroscopy guided biopsy.
Fluorescence-aided confocal endomicroscopy guided biopsy.
• Random four-quadrant biopsies.
Random four-quadrant biopsies.

Locations
Country Name City State
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Whether specialized columnar epithelium was detected. At biopsy on Day 0. No
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