Back to resultsA Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies
Primary Purpose
Barrett's Esophagus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluorescence-aided confocal endomicroscopy guided biopsy.
Random four-quadrant biopsies.
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett's Esophagus
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CEM
RFQ
Arm Description
Biopsies obtained with fluorescence-aided confocal endomicroscopy.
Random four-quadrant biopsies.
Outcomes
Primary Outcome Measures
Whether specialized columnar epithelium was detected.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01030263
Brief Title
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
The investigators left the institution.
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEM
Arm Type
Experimental
Arm Description
Biopsies obtained with fluorescence-aided confocal endomicroscopy.
Arm Title
RFQ
Arm Type
Other
Arm Description
Random four-quadrant biopsies.
Intervention Type
Other
Intervention Name(s)
Fluorescence-aided confocal endomicroscopy guided biopsy.
Intervention Description
Fluorescence-aided confocal endomicroscopy guided biopsy.
Intervention Type
Other
Intervention Name(s)
Random four-quadrant biopsies.
Intervention Description
Random four-quadrant biopsies.
Primary Outcome Measure Information:
Title
Whether specialized columnar epithelium was detected.
Time Frame
At biopsy on Day 0.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ananya Das, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies
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