OCT Pilot in Esophagus

Duke University

Status: Completed

Conditions: Barrett Esophagus

Treatments: Device: optical coherence tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03434834

R01CA210544 (U.S. NIH Grant/Contract)

Pro00090173

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

OCT of esophagus

Experimental group

Description:

optical coherence tomography of esophagus

Treatment:

Device: optical coherence tomography