Confocal Laser Probe to Treat Barrett's Esophagus

Barrett's Esophagus Clinical Trial

— pCLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852525
• Other study ID #: Barrett's Confocal
• 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

• Barrett Esophagus
• Barrett's Esophagus

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