Confocal Laser Probe to Treat Barrett's Esophagus
pCLE
Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy
1 other identifier
interventional
29
1 country
2
Brief Summary
The purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedAugust 2, 2016
July 1, 2016
1.8 years
January 21, 2014
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia
30 minutes up to an hour on average after undergoing endoscopy
Secondary Outcomes (1)
Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia
30 minutes up to an hour on average after undergoing endoscopy
Study Arms (1)
Confocal laser endomicroscopy (pCLE)
OTHERPatients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.
Interventions
Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction
Eligibility Criteria
You may qualify if:
- Must be greater than 18 years of age
- currently undergoing EGD
- previous diagnosis of Barrett's Esophagus
- long-standing GERD of greater than 5 years
- undergoing therapy for previously diagnosed Barrett's Esophagus
You may not qualify if:
- Under 19 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virendra Joshilead
Study Sites (2)
Oschsner Medical Center-Kenner
Kenner, Louisiana, 70065, United States
Ochsner Medical Center-Jefferson Highway
New Orleans, Louisiana, 70121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virendra Joshi, MD
Ochsner Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Virendra Joshi,MD
Study Record Dates
First Submitted
January 21, 2014
First Posted
August 2, 2016
Study Start
February 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 2, 2016
Record last verified: 2016-07