A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

NCT ID: NCT01030263

Last Updated: 2010-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CEM

Biopsies obtained with fluorescence-aided confocal endomicroscopy.

Group Type EXPERIMENTAL

Fluorescence-aided confocal endomicroscopy guided biopsy.

Intervention Type OTHER

Fluorescence-aided confocal endomicroscopy guided biopsy.

RFQ

Random four-quadrant biopsies.

Group Type OTHER

Random four-quadrant biopsies.

Intervention Type OTHER

Random four-quadrant biopsies.

Interventions

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Fluorescence-aided confocal endomicroscopy guided biopsy.

Fluorescence-aided confocal endomicroscopy guided biopsy.

Intervention Type OTHER

Random four-quadrant biopsies.

Random four-quadrant biopsies.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Ananya Das, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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08-001090

Identifier Type: -

Identifier Source: org_study_id

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