OCT Pilot in Esophagus

Completed · Not applicable

Conditions studied: Barrett Esophagus

In brief

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.

Key facts

Study ID

NCT03434834

Run by

Duke University

People needed

53

Starts

2018-09-25

Expected to finish

2020-03-25

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presenting to University of North Carolina (UNC) for routine care upper endoscopy
• Meet one of the following criteria:
• 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,
• History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
• Aged 18 to 80
• Able to read, comprehend, and understand the informed consent document.

You may not qualify if…

• Prior esophageal surgery (uncomplicated nissen fundoplication OK)
• Pregnant women
• Unable to provide written informed consent

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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