search
Back to results

Confocal Laser Probe to Treat Barrett's Esophagus (pCLE)

Primary Purpose

Barrett's Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Confocal laser endomicroscopy (pCLE)
Sponsored by
Virendra Joshi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oschsner Medical Center-Kenner
  • Ochsner Medical Center-Jefferson Highway

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Confocal laser endomicroscopy (pCLE)

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia

Secondary Outcome Measures

Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia

Full Information

First Posted
January 21, 2014
Last Updated
July 28, 2016
Sponsor
Virendra Joshi
search

1. Study Identification

Unique Protocol Identification Number
NCT02852525
Brief Title
Confocal Laser Probe to Treat Barrett's Esophagus
Acronym
pCLE
Official Title
Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Virendra Joshi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Confocal laser endomicroscopy (pCLE)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Confocal laser endomicroscopy (pCLE)
Intervention Description
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
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia
Time Frame
30 minutes up to an hour on average after undergoing endoscopy
Secondary Outcome Measure Information:
Title
Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia
Time Frame
30 minutes up to an hour on average after undergoing endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virendra Joshi, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oschsner Medical Center-Kenner
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Ochsner Medical Center-Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Confocal Laser Probe to Treat Barrett's Esophagus

We'll reach out to this number within 24 hrs