NCT01030263

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 25, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

December 7, 2009

Last Update Submit

March 24, 2010

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

  • Whether specialized columnar epithelium was detected.

    At biopsy on Day 0.

Study Arms (2)

CEM

EXPERIMENTAL

Biopsies obtained with fluorescence-aided confocal endomicroscopy.

Other: Fluorescence-aided confocal endomicroscopy guided biopsy.

RFQ

OTHER

Random four-quadrant biopsies.

Other: Random four-quadrant biopsies.

Interventions

Fluorescence-aided confocal endomicroscopy guided biopsy.OTHER

Fluorescence-aided confocal endomicroscopy guided biopsy.

CEM
Random four-quadrant biopsies.OTHER

Random four-quadrant biopsies.

RFQ

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ananya Das, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 11, 2009

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 25, 2010

Record last verified: 2010-03

Locations

US(1)