OCT Pilot in Esophagus



Status:Enrolling by invitation
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/27/2019
Start Date:September 25, 2018
End Date:July 2019

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Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study

This is a pilot study to test a newly developed optical coherence tomography (OCT) device to
determine 1) whether adequate tissue contact can be attained to acquire high quality images,
and 2) to identify if these images can discern whether the imaged tissue is squamous or
Barrett's Esophagus (BE) epithelium.


Inclusion Criteria:

1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy

2. Meet one of the following criteria:

1. Presenting to UNC for upper endoscopy of GI conditions without esophageal
symptomology for with no history of gastroesophageal reflux disease (GERD) or
other esophageal condition affecting the epithelium (asymptomatic controls), OR,

2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria
C1+ or M3+

3. Aged 18 to 80

4. Able to read, comprehend, and understand the informed consent document.

Exclusion Criteria:

1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)

2. Pregnant women

3. Unable to provide written informed consent
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Nicholas J Shaheen, M.D.
Phone: 919-955-2513
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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