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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852525
Other study ID # Barrett's Confocal
Secondary ID
Status Completed
Phase N/A
First received January 21, 2014
Last updated July 28, 2016
Start date February 2014
Est. completion date December 2015

Study information

Verified date July 2016
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Subject Population

Approximately 100 subjects will be recruited, age greater than 18 years. Subjects will be recruited from OCF, OMC Kenner who are undergoing EGD for either 1) screening for Barrett's Esophagus because of long-standing GERD of greater than 5 years; 2) surveillance of known Barrett's Esophagus; or 3) therapy for known Barrett's Esophagus. They will be asked to volunteer for participation at the time of their EGD. These subjects are being recruited because of a high suspicion or known diagnosis of Barrett's Esophagus in this cohort.

Procedures

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. 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.

The time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. The research will occur at OMC, Jefferson Highway and Ochsner Medical Center, Kenner.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Under 19 years of age

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Confocal laser endomicroscopy (pCLE)
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

Locations

Country Name City State
United States Oschsner Medical Center-Kenner Kenner Louisiana
United States Ochsner Medical Center-Jefferson Highway New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Virendra Joshi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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