OCT Pilot in Esophagus

Duke University53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Barrett Esophagus

Interventions

optical coherence tomographyDEVICE

OCT measurements of 5 locations in the esophagus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa

Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

Time frame: at baseline

Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa

Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.

Time frame: at baseline

Secondary Outcomes

Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image

Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.

Time frame: at baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.