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Confocal Laser Probe to Treat Barrett's Esophagus

Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02852525
Acronym
pCLE
Enrollment
29
Registered
2016-08-02
Start date
2014-02-28
Completion date
2015-12-31
Last updated
2016-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus

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.

Interventions

DEVICEConfocal 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

Sponsors

Virendra Joshi
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia30 minutes up to an hour on average after undergoing endoscopy

Secondary

MeasureTime frame
Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia30 minutes up to an hour on average after undergoing endoscopy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026