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A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

This study has been terminated.
(The investigators left the institution.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01030263
First Posted: December 11, 2009
Last Update Posted: March 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Barrett's Esophagus Other: Fluorescence-aided confocal endomicroscopy guided biopsy. Other: Random four-quadrant biopsies. Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Whether specialized columnar epithelium was detected. [ Time Frame: At biopsy on Day 0. ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEM
Biopsies obtained with fluorescence-aided confocal endomicroscopy.
Other: Fluorescence-aided confocal endomicroscopy guided biopsy.
Fluorescence-aided confocal endomicroscopy guided biopsy.
RFQ
Random four-quadrant biopsies.
Other: Random four-quadrant biopsies.
Random four-quadrant biopsies.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030263


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ananya Das, MD Mayo Clinic
  More Information

Responsible Party: Ananya Das MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01030263     History of Changes
Other Study ID Numbers: 08-001090
First Submitted: December 7, 2009
First Posted: December 11, 2009
Last Update Posted: March 25, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases